A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults

• ClinicalTrials.gov Identifier: NCT03784079
• Recruitment Status: Completed
• First Posted: December 21, 2018
• Results First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Sponsor: ViiV Healthcare
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: HIV Infections
• Interventions: Drug: GSK3640254; Drug: Placebo matching GSK3640254 Mesylate salt
• Enrollment: 34

Participant Flow

Recruitment Details	This was a randomized, double-blind, placebo-controlled, adaptive clinical trial to evaluate the antiviral effect, safety, tolerability and pharmacokinetic (PK)/pharmacodynamics (PD) of GSK3640254 over 10 days in study Part 1 and over 7 days in study Part 2.
Pre-assignment Details	A total of 34 participants (14 participants in Part 1 and 20 participants in Part 2) were enrolled in this study. This study was conducted in France, Germany, Italy, South Africa and Spain.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description	Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Period Title: Part 1: Up to Day 24
Started	6	6	2	0	0	0	0
Completed	6	6	2	0	0	0	0
Not Completed	0	0	0	0	0	0	0
Period Title: Part 2: Up to Day 12
Started	0	0	0	6	6	6	2
Completed	0	0	0	6	6	6	2
Not Completed	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo	Total
Arm/Group Description		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Total of all reporting groups
Overall Number of Baseline Participants		6	6	2	6	6	6	2	34
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	2 participants	6 participants	6 participants	6 participants	2 participants	34 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	19-64 years	6 100.0%	6 100.0%	2 100.0%	6 100.0%	6 100.0%	6 100.0%	2 100.0%	34 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	2 participants	6 participants	6 participants	6 participants	2 participants	34 participants
	Female	0 0.0%	0 0.0%	0 0.0%	1 16.7%	0 0.0%	1 16.7%	0 0.0%	2 5.9%
	Male	6 100.0%	6 100.0%	2 100.0%	5 83.3%	6 100.0%	5 83.3%	2 100.0%	32 94.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	2 participants	6 participants	6 participants	6 participants	2 participants	34 participants
	American Indian or Alaska Native	2 33.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 50.0%	3 8.8%
	Asian: South East Asian Heritage	1 16.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.9%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	1 16.7%	2 33.3%	1 16.7%	0 0.0%	4 11.8%
	White: White/Caucasian/European Heritage	2 33.3%	5 83.3%	2 100.0%	5 83.3%	4 66.7%	5 83.3%	1 50.0%	24 70.6%
	Multiple: American Indian or Alaska Native & White	1 16.7%	1 16.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 5.9%

Outcome Measures

1. Primary Outcome

Title	Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11
Description	Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. A HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Day 11

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Exposed Population consisted of all participants who met study criteria and were enrolled into the study with documented evidence of having received at least 1 dose of treatment and at least one post-Baseline HIV-1 RNA measurement.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Copies per milliliter
	-8605.8 (4604.40)	-100719.8 (89182.99)	-3406.5 (2591.55)

2. Primary Outcome

Title	Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8
Description	Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. An HIV-1 RNA PCR assay with an LLOD of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Day 8

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Exposed Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Copies per milliliter
	-48655.0 (26269.41)	-37904.3 (38814.54)	-64904.2 (83798.67)	-123478.5 (175276.92)

3. Secondary Outcome

Title	Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Description	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment. Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Time Frame	Up to Day 24

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Measure Type: Count of Participants; Unit of Measure: Participants
Non-SAEs	3 50.0%	5 83.3%	0 0.0%
SAEs	1 16.7%	0 0.0%	0 0.0%

4. Secondary Outcome

Title	Part 2: Number of Participants With Non-SAEs and SAEs
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment.
Time Frame	Up to Day 12

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Measure Type: Count of Participants; Unit of Measure: Participants
Non-SAEs	5 83.3%	4 66.7%	4 66.7%	0 0.0%
SAEs	0 0.0%	0 0.0%	1 16.7%	0 0.0%

5. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Basophils	0.005 (0.0266)	-0.017 (0.0234)	0.015 (0.0212)
Eosinophils	-0.023 (0.1296)	0.058 (0.1134)	-0.025 (0.0212)
Lymphocytes	-0.027 (0.5267)	0.458 (0.4412)	0.070 (0.0566)
Monocytes	0.100 (0.1124)	-0.000 (0.0980)	0.055 (0.0212)
Neutrophils	-0.045 (0.4624)	-0.525 (0.8169)	0.345 (0.1485)
Leukocytes	0.02 (0.679)	-0.02 (1.057)	0.45 (0.212)
Platelet count	25.0 (46.35)	11.8 (12.04)	13.0 (2.83)

6. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
	-4.2 (4.96)	-1.8 (5.98)	-1.0 (5.66)

7. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
	-0.0117 (0.01684)	-0.0073 (0.01919)	-0.0010 (0.01838)

8. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
	-0.10 (0.190)	-0.07 (0.197)	0.00 (0.141)

9. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Femtoliter
	0.0 (0.89)	-0.3 (1.03)	0.0 (0.00)

10. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Picograms
	-0.08 (0.286)	0.03 (0.266)	-0.15 (0.071)

11. Secondary Outcome

Title	Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythrocyte (erythro). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Percentage of reticulocytes in erythro
	0.0042 (0.00449)	0.0012 (0.00172)	0.0020 (0.00000)

12. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		5	6	6	2
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Basophils, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		0.010 (0.0141)	0.020 (0.0237)	0.022 (0.0084)	-0.005 (0.0354)
Eosinophils, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		-0.066 (0.2145)	-0.047 (0.1775)	0.034 (0.0404)	0.020 (0.0000)
Lymphocytes, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		0.006 (0.4458)	-0.062 (0.4731)	0.536 (0.4766)	-0.110 (0.2687)
Monocytes, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		-0.020 (0.0869)	0.022 (0.1705)	-0.084 (0.1436)	-0.130 (0.1131)
Neutrophils, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		0.424 (0.6401)	1.678 (2.1754)	0.432 (0.7007)	-0.215 (0.3182)
Leukocytes, n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		0.34 (0.385)	1.62 (2.244)	0.52 (1.211)	-0.45 (0.071)
Platelet count, n=4,6,6,2	Number Analyzed	4 participants	6 participants	6 participants	2 participants
		1.5 (45.82)	17.5 (30.26)	16.0 (21.57)	4.5 (0.71)

13. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
	-8.0 (5.10)	-4.7 (6.59)	-1.7 (7.31)	-8.0 (1.41)

14. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6	6	2
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
	-0.0230 (0.01762)	-0.0123 (0.02096)	-0.0058 (0.02094)	-0.0315 (0.01485)

15. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6	6	2
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
	-0.24 (0.207)	-0.17 (0.216)	-0.08 (0.223)	-0.30 (0.000)

16. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6	6	2
Mean (Standard Deviation); Unit of Measure: Femtoliter
	-0.2 (0.45)	0.2 (0.98)	0.2 (0.98)	-2.0 (2.83)

17. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6	6	2
Mean (Standard Deviation); Unit of Measure: Picograms
	-0.28 (0.850)	-0.05 (0.187)	-0.02 (0.337)	-0.05 (0.354)

18. Secondary Outcome

Title	Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro
Description	Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6	6	2
Mean (Standard Deviation); Unit of Measure: Percentage of reticulocytes in erythro
	0.0030 (0.00235)	0.0017 (0.00258)	0.0007 (0.00350)	0.0020 (0.00283)

19. Secondary Outcome

Title	Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Glucose, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		-0.20 (0.253)	0.28 (0.595)	0.00 (0.424)
Cholesterol, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants
Triglycerides, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants
Calcium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		-0.007 (0.1343)	-0.027 (0.0468)	0.020 (0.0283)
Chloride, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.0 (2.10)	0.8 (3.06)	-0.5 (3.54)
Phosphate, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.042 (0.1594)	0.058 (0.1772)	-0.075 (0.1061)
Potassium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.02 (0.240)	-0.03 (0.242)	-0.10 (0.000)
Magnesium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.000 (0.0551)	-0.007 (0.0561)	-0.020 (0.0283)
Sodium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.2 (2.40)	-0.8 (1.60)	-1.0 (1.41)
Urea, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		-0.08 (1.021)	-0.08 (0.801)	1.00 (0.000)
HDL cholesterol, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants
LDL cholesterol, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants

20. Secondary Outcome

Title	Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: International units per liter
ALT	2.7 (7.79)	-1.7 (4.46)	9.5 (6.36)
ALP	10.5 (23.36)	-3.5 (4.64)	-4.0 (1.41)
AST	-0.5 (3.94)	-2.0 (8.60)	4.5 (2.12)

21. Secondary Outcome

Title	Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Creatinine	1.77 (5.565)	-1.33 (4.291)	0.00 (0.000)
Bilirubin	-0.3 (3.20)	-2.0 (2.53)	3.0 (9.90)

22. Secondary Outcome

Title	Part 1: Change From Baseline in Chemistry Parameters: Protein
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
	-1.3 (4.93)	-1.0 (2.97)	1.0 (2.83)

23. Secondary Outcome

Title	Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 6 (Day 11)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed. Amylase and lipase results were collected for two participants in GSK3640254 10 mg arm during Part 1 of the study. No data were collected for Placebo and GSK3640254 200 mg arms at Visit 6 (Day 11) due to delays in approval of Protocol Amendment 02 into which testing for amylase and lipase was added.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	2	0	0
Mean (Standard Deviation); Unit of Measure: Units per liter
Amylase	0.0 (11.31)
Lipase	-2.0 (2.83)

24. Secondary Outcome

Title	Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	1
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Glucose, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.05 (0.327)	0.18 (1.085)	-0.03 (0.446)	0.50 [1] (NA)
Cholesterol, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants
Triglycerides, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants
Calcium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.057 (0.0638)	-0.027 (0.0628)	0.030 (0.1002)	0.000 [1] (NA)
Chloride, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.7 (2.25)	-0.2 (1.47)	-0.7 (2.34)	-2.0 [1] (NA)
Phosphate, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.117 (0.2160)	0.067 (0.1211)	0.083 (0.1329)	0.000 [1] (NA)
Potassium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.20 (0.261)	0.05 (0.383)	0.20 (0.210)	-0.10 [1] (NA)
Magnesium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		0.007 (0.0484)	0.007 (0.0413)	0.027 (0.0501)	0.000 [1] (NA)
Sodium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.8 (2.23)	-0.3 (1.37)	-0.2 (1.72)	-4.0 [1] (NA)
Urea, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		-0.42 (0.861)	-0.25 (1.037)	-0.33 (0.931)	-0.50 [1] (NA)
HDL cholesterol, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants
LDL cholesterol, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants

[1]

Standard deviation could not be calculated for single participant.

25. Secondary Outcome

Title	Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST
Description	Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	1
Mean (Standard Deviation); Unit of Measure: International units per liter
ALT	-3.8 (6.62)	-1.2 (3.76)	-6.2 (8.33)	-1.0 [1] (NA)
ALP	-3.2 (3.19)	-0.7 (5.35)	-1.8 (8.61)	-1.0 [1] (NA)
AST	-5.2 (9.37)	0.3 (5.79)	-4.7 (7.37)	4.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

26. Secondary Outcome

Title	Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	1
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Creatinine	1.35 (3.230)	-3.38 (2.230)	-0.17 (8.362)	-0.90 [1] (NA)
Bilirubin	-0.3 (2.34)	1.3 (6.02)	0.3 (1.51)	0.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

27. Secondary Outcome

Title	Part 2: Change From Baseline in Chemistry Parameters: Protein
Description	Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	1
Mean (Standard Deviation); Unit of Measure: Grams per liter
	-2.2 (3.25)	-0.8 (4.07)	1.5 (4.64)	-2.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

28. Secondary Outcome

Title	Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	1
Mean (Standard Deviation); Unit of Measure: Units per liter
Amylase	-2.3 (8.62)	0.8 (9.87)	6.7 (7.84)	-10.0 [1] (NA)
Lipase	-1.0 (8.27)	-2.2 (6.37)	4.5 (8.29)	8.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

29. Secondary Outcome

Title	Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Description	Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Ratio
	0.0002 (0.00615)	0.0008 (0.00232)	0.0000 (0.00283)

30. Secondary Outcome

Title	Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
	4.50 (6.971)	0.00 (0.000)	0.00 (0.000)

31. Secondary Outcome

Title	Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
Description	Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: pH
	0.17 (1.033)	-0.33 (0.683)	-0.50 (0.000)

32. Secondary Outcome

Title	Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Description	Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Ratio
	0.0010 (0.00746)	-0.0022 (0.00794)	0.0018 (0.00744)	-0.0110 (0.00424)

33. Secondary Outcome

Title	Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
	0.00 (0.000)	4.50 (6.971)	0.00 (0.000)	0.00 (0.000)

34. Secondary Outcome

Title	Part 2: Change From Baseline in Urinalysis Parameter: pH
Description	Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: pH
	0.17 (0.683)	-0.17 (0.683)	0.08 (0.492)	0.25 (0.354)

35. Secondary Outcome

Title	Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Millimeters of mercury
SBP	-2.5 (8.41)	0.5 (9.65)	-1.5 (3.54)
DBP	-0.3 (14.50)	0.8 (4.67)	0.5 (0.71)

36. Secondary Outcome

Title	Part 1: Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Breaths per minute
	-1.0 (1.79)	0.2 (2.32)	-1.0 (1.41)

37. Secondary Outcome

Title	Part 1: Change From Baseline in Pulse Rate
Description	Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Beats per minute
	-5.2 (4.36)	5.5 (10.99)	6.0 (2.83)

38. Secondary Outcome

Title	Part 2: Change From Baseline in SBP and DBP
Description	SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Millimeters of mercury
SBP	1.0 (8.27)	-2.2 (4.45)	7.3 (11.55)	1.0 (2.83)
DBP	-1.8 (2.40)	-1.0 (6.36)	2.3 (15.72)	-0.5 (7.78)

39. Secondary Outcome

Title	Part 2: Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Breaths per minute
	-0.2 (1.83)	0.2 (1.47)	-1.0 (4.47)	0.5 (2.12)

40. Secondary Outcome

Title	Part 2: Change From Baseline in Pulse Rate
Description	Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Beats per minute
	4.2 (17.36)	2.0 (11.14)	2.8 (6.40)	10.5 (7.78)

41. Secondary Outcome

Title	Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF)
Description	Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Milliseconds
PR Interval- Days 8 to 10: Pre-dose	-0.4 (5.32)	-7.6 (5.69)	-2.5 (2.12)
PR Interval- Days 8 to 10: 2 hours	1.4 (5.47)	-6.3 (9.71)	-11.5 (0.71)
PR Interval- Days 8 to 10: 4 hours	-0.1 (10.00)	0.2 (9.81)	-3.5 (0.71)
PR Interval- Days 8 to 10: 6 hours	1.4 (13.22)	-5.9 (3.93)	-25.0 (4.24)
QRS Duration- Days 8 to 10: Pre-dose	-3.1 (6.65)	-3.4 (9.90)	-5.3 (3.30)
QRS Duration- Days 8 to 10: 2 hours	-2.1 (6.60)	0.4 (6.27)	0.2 (4.01)
QRS Duration- Days 8 to 10: 4 hours	-3.3 (3.50)	-1.7 (6.75)	-1.3 (3.77)
QRS Duration- Days 8 to 10: 6 hours	-3.6 (5.56)	-2.9 (4.55)	-2.3 (13.20)
QT Interval- Days 8 to 10: Pre-dose	0.7 (8.15)	-2.7 (19.60)	-19.7 (21.21)
QT Interval- Days 8 to 10: 2 hours	-2.4 (17.61)	4.4 (20.33)	-28.7 (4.24)
QT Interval- Days 8 to 10: 4 hours	8.7 (18.43)	8.9 (13.72)	-25.2 (19.09)
QT Interval- Days 8 to 10: 6 hours	5.7 (16.48)	5.8 (14.19)	-24.2 (21.92)
QTcB Interval- Days 8 to 10: Pre-dose	1.65 (15.813)	3.60 (18.218)	-1.38 (6.435)
QTcB Interval- Days 8 to 10: 2 hours	-10.45 (22.433)	-4.60 (14.266)	-27.38 (32.315)
QTcB Interval- Days 8 to 10: 4 hours	0.77 (15.517)	-10.37 (20.176)	-30.23 (51.760)
QTcB Interval- Days 8 to 10: 6 hours	2.65 (13.391)	-9.15 (15.513)	-4.88 (11.102)
QTcF Interval- Days 8 to 10: Pre-dose	1.2 (10.75)	1.2 (9.56)	-7.7 (11.31)
QTcF Interval- Days 8 to 10: 2 hours	-7.5 (19.44)	-1.3 (14.06)	-27.7 (22.63)
QTcF Interval- Days 8 to 10: 4 hours	3.7 (15.18)	-3.7 (10.84)	-28.7 (41.01)
QTcF Interval- Days 8 to 10: 6 hours	4.0 (12.82)	-3.8 (13.06)	-12.2 (14.85)

42. Secondary Outcome

Title	Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF
Description	Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time Frame	Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Milliseconds
PR Interval- Day 7: Pre-dose	9.7 (13.92)	-1.1 (6.89)	-7.3 (9.20)	-7.3 (0.47)
PR Interval- Day 7: 2 hours	6.1 (14.20)	-2.4 (7.90)	-3.1 (8.61)	6.2 (2.59)
PR Interval- Day 7: 4 hours	5.2 (22.87)	1.1 (8.56)	-8.3 (6.81)	4.7 (5.19)
PR Interval- Day 7: 6 hours	3.9 (16.80)	-2.3 (6.24)	-2.1 (5.82)	-7.8 (9.66)
QRS Duration- Day 7: Pre-dose	3.9 (5.11)	3.2 (7.81)	-0.4 (6.87)	2.3 (7.07)
QRS Duration- Day 7: 2 hours	2.4 (4.18)	0.7 (4.89)	-0.1 (8.45)	4.3 (1.41)
QRS Duration- Day 7: 4 hours	1.7 (4.06)	0.1 (4.41)	-3.1 (6.25)	3.8 (3.54)
QRS Duration- Day 7: 6 hours	0.5 (11.78)	-0.1 (3.04)	-0.8 (3.70)	2.8 (6.36)
QT Interval- Day 7: Pre-dose	-7.4 (33.78)	-1.6 (13.03)	5.0 (20.49)	3.2 (2.59)
QT Interval- Day 7: 2 hours	-24.4 (33.17)	-4.4 (8.90)	1.8 (12.60)	-0.3 (6.13)
QT Interval- Day 7: 4 hours	-12.8 (25.96)	4.2 (12.84)	-1.7 (13.65)	11.2 (19.56)
QT Interval- Day 7: 6 hours	-21.4 (36.18)	5.9 (12.19)	0.7 (12.92)	2.7 (7.54)
QTcB Interval- Day 7: Pre-dose	-4.16 (14.780)	0.34 (11.468)	3.45 (6.785)	-7.08 (2.569)
QTcB Interval- Day 7: 2 hours	2.90 (19.936)	0.09 (14.494)	-4.88 (17.444)	-18.23 (2.923)
QTcB Interval- Day 7: 4 hours	-6.96 (23.150)	-0.56 (13.559)	1.30 (14.341)	-23.83 (2.781)
QTcB Interval- Day 7: 6 hours	-3.26 (16.691)	4.17 (12.302)	-1.68 (10.181)	-9.83 (17.489)
QTcF Interval- Day 7: Pre-dose	-5.9 (18.89)	-0.5 (4.12)	4.1 (9.23)	-3.3 (0.94)
QTcF Interval- Day 7: 2 hours	-7.2 (22.91)	-1.3 (8.73)	-2.3 (12.87)	-12.3 (0.47)
QTcF Interval- Day 7: 4 hours	-9.4 (21.24)	1.2 (8.15)	0.6 (9.00)	-12.3 (4.71)
QTcF Interval- Day 7: 6 hours	-9.5 (19.08)	4.5 (5.69)	-0.8 (7.79)	-5.8 (8.72)

43. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Baseline (Day 1): Basophils, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		0.052 (0.0279)	0.056 (0.0321)	0.030 (0.0000)
Days 8 to 10: Basophils, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.057 (0.0266)	0.037 (0.0186)	0.045 (0.0212)
Baseline (Day 1): Eosinophils, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		0.212 (0.1783)	0.150 (0.0616)	0.105 (0.0212)
Days 8 to 10: Eosinophils, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.188 (0.0873)	0.202 (0.1003)	0.080 (0.0424)
Baseline (Day 1): Lymphocytes, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		2.303 (0.5431)	1.810 (0.4341)	2.010 (0.0707)
Days 8 to 10: Lymphocytes, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		2.277 (0.4484)	2.217 (0.6693)	2.080 (0.1273)
Baseline (Day 1): Monocytes, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		0.552 (0.2033)	0.530 (0.1814)	0.460 (0.0000)
Days 8 to 10: Monocytes, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.652 (0.1907)	0.508 (0.2088)	0.515 (0.0212)
Baseline (Day 1): Neutrophils, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		2.935 (0.4803)	3.094 (0.7279)	1.840 (0.4101)
Days 8 to 10: Neutrophils, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		2.890 (0.6049)	2.635 (0.4068)	2.185 (0.2616)
Baseline (Day 1): Leukocytes, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		6.05 (1.071)	5.64 (1.172)	4.45 (0.495)
Days 8 to 10: Leukocytes, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		6.07 (0.929)	5.60 (1.158)	4.90 (0.283)
Baseline (Day 1): Platelet count, n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		208.8 (38.48)	202.0 (39.26)	195.5 (12.02)
Days 8 to 10: Platelet count, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		233.8 (70.34)	205.0 (43.38)	208.5 (14.85)

44. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
Baseline (Day 1): n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		144.2 (11.55)	135.4 (9.42)	148.0 (4.24)
Days 8 to 10: n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		140.0 (12.18)	138.7 (12.72)	147.0 (9.90)

45. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
Baseline (Day 1): n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		0.4338 (0.02709)	0.4112 (0.02523)	0.4395 (0.01344)
Days 8 to 10: n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.4222 (0.03456)	0.4158 (0.02827)	0.4385 (0.03182)

46. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
Baseline (Day 1): n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		4.90 (0.228)	4.58 (0.259)	4.90 (0.283)
Days 8 to 10: n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		4.80 (0.290)	4.63 (0.327)	4.90 (0.424)

47. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Femtoliter
Baseline (Day 1): n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		88.5 (3.67)	90.2 (3.49)	90.0 (1.41)
Days 8 to 10: n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		88.5 (4.09)	90.0 (2.28)	90.0 (1.41)

48. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Picograms
Baseline (Day 1): n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		29.38 (1.780)	29.64 (0.879)	30.25 (0.636)
Days 8 to 10: n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		29.30 (1.747)	29.97 (0.942)	30.10 (0.707)

49. Secondary Outcome

Title	Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Percentage of reticulocytes in erythro
Baseline (Day 1): n=6,5,2	Number Analyzed	6 participants	5 participants	2 participants
		0.0137 (0.00726)	0.0078 (0.00349)	0.0110 (0.00424)
Days 8 to 10: n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.0178 (0.01139)	0.0088 (0.00264)	0.0130 (0.00424)

50. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Baseline (Day 1): Basophils, n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		0.042 (0.0232)	0.042 (0.0117)	0.030 (0.0200)	0.040 (0.0283)
Day 7: Basophils, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		0.050 (0.0274)	0.062 (0.0223)	0.054 (0.0251)	0.035 (0.0071)
Baseline (Day 1): Eosinophils, n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		0.402 (0.3307)	0.290 (0.2628)	0.320 (0.2542)	0.055 (0.0354)
Day 7: Eosinophils, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		0.316 (0.1780)	0.243 (0.1546)	0.210 (0.1239)	0.075 (0.0354)
Baseline (Day 1): Lymphocytes, n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		1.990 (0.3013)	2.047 (0.6167)	2.236 (0.3010)	1.865 (0.3606)
Day 7: Lymphocytes, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		1.960 (0.3450)	1.985 (0.2983)	2.694 (0.7060)	1.755 (0.0919)
Baseline (Day 1): Monocytes, n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		0.560 (0.2082)	0.477 (0.1442)	0.534 (0.1459)	0.435 (0.1061)
Day 7: Monocytes, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		0.530 (0.2210)	0.498 (0.2647)	0.414 (0.1467)	0.305 (0.0071)
Baseline (Day 1): Neutrophils, n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		2.512 (1.2631)	2.442 (1.1951)	3.060 (0.5711)	2.280 (1.0465)
Day 7: Neutrophils, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		2.826 (1.1821)	4.120 (2.9025)	3.344 (0.6322)	2.065 (1.3647)
Baseline (Day 1): Leukocytes, n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		5.50 (1.633)	5.28 (1.947)	6.20 (0.938)	4.65 (1.485)
Day 7: Leukocytes, n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		5.66 (1.527)	6.90 (3.310)	6.55 (0.973)	4.20 (1.414)
Baseline (Day 1): Platelet count, n=5,6,5,2	Number Analyzed	5 participants	6 participants	5 participants	2 participants
		276.6 (54.29)	236.7 (41.87)	232.2 (40.12)	197.0 (59.40)
Day 7: Platelet count, n=4,6,6,2	Number Analyzed	4 participants	6 participants	6 participants	2 participants
		292.0 (77.06)	254.2 (37.39)	249.0 (38.72)	201.5 (60.10)

51. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
Baseline (Day 1): n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		136.3 (16.34)	149.2 (13.44)	141.2 (7.98)	147.0 (7.07)
Day 7: n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		129.4 (19.55)	144.5 (7.87)	135.8 (11.02)	139.0 (8.49)

52. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
Baseline (Day 1): n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		0.4037 (0.04646)	0.4505 (0.02992)	0.4222 (0.01879)	0.4330 (0.01838)
Day 7: n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		0.3826 (0.05125)	0.4382 (0.01579)	0.4062 (0.03107)	0.4015 (0.03323)

53. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
Baseline (Day 1): n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		4.53 (0.476)	5.17 (0.450)	4.74 (0.230)	4.80 (0.000)
Day 7: n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		4.26 (0.503)	5.00 (0.518)	4.52 (0.431)	4.50 (0.000)

54. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Femtoliter
Baseline (Day 1): n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		88.8 (3.76)	87.8 (8.59)	89.2 (1.64)	91.0 (4.24)
Day 7: n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		89.6 (3.44)	88.0 (8.53)	90.0 (2.97)	89.0 (7.07)

55. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Picograms
Baseline (Day 1): n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		30.07 (1.870)	29.15 (3.531)	29.80 (0.925)	30.95 (1.485)
Day 7: n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		30.22 (2.017)	29.10 (3.553)	29.97 (0.898)	30.90 (1.838)

56. Secondary Outcome

Title	Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro
Description	Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Percentage of reticulocytes in erythro
Baseline (Day 1): n=6,6,5,2	Number Analyzed	6 participants	6 participants	5 participants	2 participants
		0.0102 (0.00223)	0.0082 (0.00147)	0.0108 (0.00492)	0.0070 (0.00141)
Day 7: n=5,6,6,2	Number Analyzed	5 participants	6 participants	6 participants	2 participants
		0.0124 (0.00297)	0.0098 (0.00160)	0.0107 (0.00344)	0.0090 (0.00141)

57. Secondary Outcome

Title	Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	2
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Baseline (Day 1): Glucose, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		5.28 (0.556)	4.88 (0.546)	5.40 (0.141)
Days 8 to 10: Glucose, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		5.08 (0.618)	5.17 (0.528)	5.40 (0.283)
Baseline (Day 1): Cholesterol, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		4.700 (1.2345)	4.058 (0.9641)	4.350 (0.6364)
Days 8 to 10: Cholesterol, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants
Baseline (Day 1): Triglycerides, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		1.070 (0.4527)	1.150 (0.5114)	0.950 (0.4101)
Days 8 to 10: Triglycerides, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants
Baseline (Day 1): Calcium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		2.300 (0.1073)	2.313 (0.0961)	2.330 (0.0141)
Days 8 to 10: Calcium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		2.293 (0.0816)	2.287 (0.0561)	2.350 (0.0424)
Baseline (Day 1): Chloride, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		104.2 (0.41)	105.8 (2.48)	105.0 (2.83)
Days 8 to 10: Chloride, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		104.2 (1.72)	106.7 (1.21)	104.5 (0.71)
Baseline (Day 1): Phosphate, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		1.117 (0.1835)	1.083 (0.1889)	1.200 (0.0707)
Days 8 to 10: Phosphate, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		1.158 (0.1882)	1.142 (0.2245)	1.125 (0.1768)
Baseline (Day 1): Potassium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		4.10 (0.210)	4.30 (0.276)	4.15 (0.212)
Days 8 to 10: Potassium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		4.12 (0.349)	4.27 (0.216)	4.05 (0.212)
Baseline (Day 1): Magnesium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.847 (0.0393)	0.853 (0.0450)	0.880 (0.0283)
Days 8 to 10: Magnesium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		0.847 (0.0561)	0.847 (0.0393)	0.860 (0.0000)
Baseline (Day 1): Sodium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		138.3 (2.25)	139.8 (0.75)	139.0 (0.00)
Days 8 to 10: Sodium, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		138.5 (2.17)	139.0 (0.89)	138.0 (1.41)
Baseline (Day 1): Urea, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		5.33 (0.516)	5.83 (1.169)	5.00 (0.707)
Days 8 to 10: Urea, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		5.25 (1.037)	5.75 (0.524)	6.00 (0.707)
Baseline (Day 1): HDL cholesterol, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		1.192 (0.1960)	1.025 (0.0612)	1.075 (0.0354)
Days 8 to 10: HDL cholesterol, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants
Baseline (Day 1): LDL cholesterol, n=6,6,2	Number Analyzed	6 participants	6 participants	2 participants
		3.017 (1.0452)	2.507 (0.7842)	2.840 (0.4808)
Days 8 to 10: LDL cholesterol, n=0,0,0	Number Analyzed	0 participants	0 participants	0 participants

58. Secondary Outcome

Title	Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: International units per liter
Baseline (Day 1): ALT	31.3 (15.67)	19.7 (15.82)	20.0 (8.49)
Days 8 to 10: ALT	34.0 (21.58)	18.0 (11.85)	29.5 (14.85)
Baseline (Day 1): ALP	62.0 (10.55)	62.3 (19.13)	63.0 (2.83)
Days 8 to 10: ALP	72.5 (27.68)	58.8 (16.46)	59.0 (1.41)
Baseline (Day 1): AST	26.7 (9.42)	23.3 (10.76)	20.0 (8.49)
Days 8 to 10: AST	26.2 (11.27)	21.3 (4.63)	24.5 (10.61)

59. Secondary Outcome

Title	Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Baseline (Day 1): Creatinine	82.05 (11.319)	81.35 (3.861)	88.40 (3.818)
Days 8 to 10: Creatinine	83.82 (13.674)	80.02 (6.239)	88.40 (3.818)
Baseline (Day 1): Bilirubin	11.7 (6.38)	8.0 (2.83)	15.0 (1.41)
Days 8 to 10: Bilirubin	11.3 (3.50)	6.0 (1.79)	18.0 (8.49)

60. Secondary Outcome

Title	Part 1: Absolute Values for Chemistry Parameters: Protein
Description	Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
Baseline (Day 1)	72.2 (3.06)	70.3 (2.34)	69.0 (1.41)
Days 8 to 10	70.8 (3.60)	69.3 (5.05)	70.0 (1.41)

61. Secondary Outcome

Title	Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 6 (Day 11)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed. Amylase and lipase results were collected for two participants in GSK3640254 10 mg arm during Part 1 of the study. No data were collected for Placebo and GSK3640254 200 mg arms at Visit 6 (Day 11) due to delays in approval of Protocol Amendment 02 into which testing for amylase and lipase was added.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	2	0	0
Mean (Standard Deviation); Unit of Measure: Units per liter
Baseline (Day 1): Amylase	57.0 (11.31)
Day 11: Amylase	57.0 (0.00)
Baseline (Day 1): Lipase	28.5 (4.95)
Day 11: Lipase	26.5 (7.78)

62. Secondary Outcome

Title	Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Baseline (Day 1): Glucose, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		4.68 (0.306)	4.72 (0.928)	4.80 (0.456)	4.90 (0.849)
Day 7: Glucose, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		4.63 (0.408)	4.90 (0.190)	4.77 (0.320)	4.80 [1] (NA)
Baseline (Day 1): Cholesterol, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		4.233 (0.6758)	4.375 (1.1626)	4.150 (0.8573)	3.400 (0.3536)
Day 7: Cholesterol, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants
Baseline (Day 1): Triglycerides, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		1.183 (0.1924)	1.447 (0.6008)	1.120 (0.4879)	0.540 (0.1980)
Day 7: Triglycerides, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants
Baseline (Day 1): Calcium, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		2.330 (0.0629)	2.320 (0.0980)	2.290 (0.0701)	2.280 (0.0849)
Day 7: Calcium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		2.273 (0.0628)	2.293 (0.0766)	2.320 (0.0780)	2.220 [1] (NA)
Baseline (Day 1): Chloride, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		103.0 (1.67)	102.2 (2.64)	103.7 (2.34)	105.5 (0.71)
Day 7: Chloride, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		102.3 (1.51)	102.0 (1.79)	103.0 (1.10)	104.0 [1] (NA)
Baseline (Day 1): Phosphate, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		1.317 (0.1693)	1.108 (0.1281)	1.083 (0.1211)	0.950 (0.2828)
Day 7: Phosphate, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		1.200 (0.1265)	1.175 (0.1969)	1.167 (0.1329)	0.750 [1] (NA)
Baseline (Day 1): Potassium, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		4.07 (0.476)	3.98 (0.325)	3.95 (0.164)	4.10 (0.424)
Day 7: Potassium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		3.87 (0.273)	4.03 (0.242)	4.15 (0.122)	3.70 [1] (NA)
Baseline (Day 1): Magnesium, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		0.790 (0.0395)	0.830 (0.0518)	0.803 (0.0320)	0.810 (0.0707)
Day 7: Magnesium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		0.797 (0.0731)	0.837 (0.0427)	0.830 (0.0654)	0.760 [1] (NA)
Baseline (Day 1): Sodium, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		137.7 (1.63)	138.5 (2.43)	137.8 (3.06)	140.5 (2.12)
Day 7: Sodium, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		136.8 (3.54)	138.2 (1.94)	137.7 (1.97)	138.0 [1] (NA)
Baseline (Day 1): Urea, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		4.50 (1.517)	4.25 (1.508)	5.92 (1.068)	6.25 (2.475)
Day 7: Urea, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		4.08 (0.970)	4.00 (0.632)	5.58 (0.492)	4.00 [1] (NA)
Baseline (Day 1): HDL cholesterol, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		1.242 (0.3277)	1.133 (0.3312)	1.200 (0.3194)	1.250 (0.0707)
Day 7: HDL cholesterol, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants
Baseline (Day 1): LDL cholesterol, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		2.448 (0.6649)	2.578 (0.8267)	2.437 (0.6955)	1.905 (0.3748)
Day 7: LDL cholesterol, n=0,0,0,0	Number Analyzed	0 participants	0 participants	0 participants	0 participants

[1]

Standard deviation could not be calculated for single participant.

63. Secondary Outcome

Title	Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST
Description	Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: International units per liter
Baseline (Day 1): ALT, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		18.3 (14.07)	17.8 (7.63)	33.2 (23.07)	34.5 (6.36)
Day 7: ALT, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		14.5 (7.66)	16.7 (5.24)	27.0 (18.00)	29.0 [1] (NA)
Baseline (Day 1): ALP, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		63.3 (15.08)	63.7 (4.68)	60.8 (9.00)	43.0 (18.38)
Day 7: ALP, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		60.2 (16.53)	63.0 (5.25)	59.0 (5.18)	55.0 [1] (NA)
Baseline (Day 1): AST, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		26.8 (15.39)	18.5 (6.60)	26.7 (8.14)	50.0 (39.60)
Day 7: AST, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		21.7 (6.74)	18.8 (3.31)	22.0 (3.74)	26.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

64. Secondary Outcome

Title	Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Baseline (Day 1): Creatinine, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		71.30 (12.207)	73.67 (7.120)	73.52 (12.761)	86.65 (13.789)
Day 7: Creatinine, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		72.65 (14.109)	70.28 (8.269)	73.35 (8.195)	76.00 [1] (NA)
Baseline (Day 1): Bilirubin, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		10.0 (5.66)	9.3 (1.03)	7.7 (3.44)	11.0 (7.07)
Day 7: Bilirubin, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		9.7 (4.97)	10.7 (5.47)	8.0 (2.83)	6.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

65. Secondary Outcome

Title	Part 2: Absolute Values for Chemistry Parameters: Protein
Description	Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Grams per liter
Baseline (Day 1): n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		78.8 (12.78)	73.3 (5.50)	76.7 (10.03)	73.5 (0.71)
Day 7: n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		76.7 (12.01)	72.5 (5.13)	78.2 (8.93)	72.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

66. Secondary Outcome

Title	Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:		Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6	6	2
Mean (Standard Deviation); Unit of Measure: Units per liter
Baseline (Day 1): Amylase, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		47.2 (18.15)	51.0 (21.65)	55.2 (18.61)	56.0 (25.46)
Day 7: Amylase, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		44.8 (17.81)	51.8 (22.71)	61.8 (25.86)	64.0 [1] (NA)
Baseline (Day 1): Lipase, n=6,6,6,2	Number Analyzed	6 participants	6 participants	6 participants	2 participants
		26.5 (14.08)	29.7 (10.95)	43.2 (32.32)	26.0 (14.14)
Day 7: Lipase, n=6,6,6,1	Number Analyzed	6 participants	6 participants	6 participants	1 participants
		25.5 (11.64)	27.5 (13.40)	47.7 (34.70)	44.0 [1] (NA)

[1]

Standard deviation could not be calculated for single participant.

67. Secondary Outcome

Title	Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Description	Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Ratio
Baseline (Day 1)	1.0238 (0.00677)	1.0233 (0.00320)	1.0240 (0.00283)
Days 8 to 10	1.0240 (0.00533)	1.0242 (0.00279)	1.0240 (0.00000)

68. Secondary Outcome

Title	Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Baseline (Day 1)	3.40 (0.000)	3.40 (0.000)	3.40 (0.000)
Days 8 to 10	7.90 (6.971)	3.40 (0.000)	3.40 (0.000)

69. Secondary Outcome

Title	Part 1: Absolute Values for Urinalysis Parameter: pH
Description	Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: pH
Baseline (Day 1)	5.67 (0.931)	5.75 (0.689)	5.75 (0.354)
Days 8 to 10	5.83 (0.753)	5.42 (0.585)	5.25 (0.354)

70. Secondary Outcome

Title	Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Description	Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Ratio
Baseline (Day 1)	1.0223 (0.00866)	1.0272 (0.00360)	1.0255 (0.00918)	1.0375 (0.00495)
Day 7	1.0233 (0.00686)	1.0250 (0.00522)	1.0273 (0.00327)	1.0265 (0.00919)

71. Secondary Outcome

Title	Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Baseline (Day 1)	3.40 (0.000)	3.40 (0.000)	3.40 (0.000)	3.40 (0.000)
Day 7	3.40 (0.000)	7.90 (6.971)	3.40 (0.000)	3.40 (0.000)

72. Secondary Outcome

Title	Part 2: Absolute Values for Urinalysis Parameter: pH
Description	Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: pH
Baseline (Day 1)	5.33 (0.258)	5.83 (0.753)	5.25 (0.418)	5.50 (0.000)
Day 7	5.50 (0.775)	5.67 (0.258)	5.33 (0.258)	5.75 (0.354)

73. Secondary Outcome

Title	Part 1: Absolute Values for SBP and DBP
Description	SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Millimeters of mercury
Baseline (Day 1): SBP	120.2 (13.36)	121.8 (12.25)	106.0 (11.31)
Days 8 to 10: SBP	117.7 (8.87)	122.3 (7.94)	104.5 (7.78)
Baseline (Day 1): DBP	70.3 (17.32)	66.7 (10.80)	64.0 (5.66)
Days 8 to 10: DBP	70.0 (6.81)	67.5 (9.91)	64.5 (4.95)

74. Secondary Outcome

Title	Part 1: Absolute Values for Respiratory Rate
Description	Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Breaths per minute
Baseline (Day 1)	16.0 (2.61)	16.2 (3.31)	15.0 (4.24)
Days 8 to 10	15.0 (1.26)	16.3 (2.73)	14.0 (2.83)

75. Secondary Outcome

Title	Part 1: Absolute Values for Pulse Rate
Description	Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Days 8 to 10)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Beats per minute
Baseline (Day 1)	81.8 (18.25)	65.8 (14.22)	60.0 (2.83)
Days 8 to 10	76.7 (21.13)	71.3 (11.93)	66.0 (5.66)

76. Secondary Outcome

Title	Part 2: Absolute Values for SBP and DBP
Description	SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Millimeters of mercury
Baseline (Day 1): SBP	117.0 (7.95)	116.5 (11.04)	112.2 (9.93)	105.5 (2.12)
Day 7: SBP	118.0 (12.07)	114.3 (8.36)	119.5 (8.87)	106.5 (4.95)
Baseline (Day 1): DBP	71.5 (4.51)	74.0 (4.69)	71.8 (12.89)	71.0 (12.73)
Day 7: DBP	69.7 (4.50)	73.0 (5.06)	74.2 (5.27)	70.5 (4.95)

77. Secondary Outcome

Title	Part 2: Absolute Values for Respiratory Rate
Description	Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Breaths per minute
Baseline (Day 1)	17.3 (2.66)	17.2 (1.17)	17.2 (2.40)	16.0 (0.00)
Day 7	17.2 (2.56)	17.3 (2.07)	16.2 (2.23)	16.5 (2.12)

78. Secondary Outcome

Title	Part 2: Absolute Values for Pulse Rate
Description	Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and Visit 5 (Day 7)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Beats per minute
Baseline (Day 1)	68.3 (9.91)	74.5 (8.36)	77.0 (10.16)	64.5 (13.44)
Day 7	72.5 (16.34)	76.5 (7.87)	79.8 (12.45)	75.0 (5.66)

79. Secondary Outcome

Title	Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals
Description	Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 1: Placebo
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	2
Mean (Standard Deviation); Unit of Measure: Milliseconds
PR Interval- Baseline (Day 1)	136.6 (14.49)	168.4 (15.48)	176.5 (27.58)
PR Interval- Days 8 to 10: Pre-dose	136.2 (15.26)	160.8 (19.60)	174.0 (29.70)
PR Interval- Days 8 to 10: 2 hours	138.0 (14.46)	162.2 (11.53)	165.0 (28.28)
PR Interval- Days 8 to 10: 4 hours	136.5 (12.10)	168.7 (13.81)	173.0 (28.28)
PR Interval- Days 8 to 10: 6 hours	138.0 (9.10)	162.5 (15.06)	151.5 (23.33)
QRS Duration- Baseline (Day 1)	93.1 (4.54)	95.7 (6.85)	85.8 (11.08)
QRS Duration- Days 8 to 10: Pre-dose	90.0 (7.46)	92.3 (7.74)	80.5 (7.78)
QRS Duration- Days 8 to 10: 2 hours	91.0 (6.36)	96.2 (7.17)	86.0 (7.07)
QRS Duration- Days 8 to 10: 4 hours	89.8 (5.91)	94.0 (6.42)	84.5 (14.85)
QRS Duration- Days 8 to 10: 6 hours	89.5 (7.04)	92.8 (10.11)	83.5 (2.12)
QT Interval- Baseline (Day 1)	367.6 (26.04)	378.7 (26.75)	372.7 (29.70)
QT Interval- Days 8 to 10: Pre-dose	368.3 (23.35)	376.0 (31.46)	353.0 (8.49)
QT Interval- Days 8 to 10: 2 hours	365.2 (25.39)	383.2 (26.84)	344.0 (25.46)
QT Interval- Days 8 to 10: 4 hours	376.3 (22.70)	387.7 (29.34)	347.5 (10.61)
QT Interval- Days 8 to 10: 6 hours	373.3 (26.48)	384.5 (25.37)	348.5 (7.78)
QTcB Interval- Baseline (Day 1)	412.15 (31.539)	397.75 (22.914)	388.43 (39.598)
QTcB Interval- Days 8 to 10: Pre-dose	413.80 (42.176)	401.35 (22.923)	387.05 (33.163)
QTcB Interval- Days 8 to 10: 2 hours	401.70 (37.316)	393.15 (26.290)	361.05 (7.283)
QTcB Interval- Days 8 to 10: 4 hours	412.92 (42.143)	387.38 (24.454)	358.20 (12.162)
QTcB Interval- Days 8 to 10: 6 hours	414.80 (34.569)	388.60 (23.893)	383.55 (28.496)
QTcF Interval- Baseline (Day 1)	396.2 (17.67)	391.2 (19.11)	383.2 (36.06)
QTcF Interval- Days 8 to 10: Pre-dose	397.3 (25.34)	392.3 (20.64)	375.5 (24.75)
QTcF Interval- Days 8 to 10: 2 hours	388.7 (22.72)	389.8 (22.89)	355.5 (13.44)
QTcF Interval- Days 8 to 10: 4 hours	399.8 (25.87)	387.5 (21.27)	354.5 (4.95)
QTcF Interval- Days 8 to 10: 6 hours	400.2 (19.22)	387.3 (22.03)	371.0 (21.21)

80. Secondary Outcome

Title	Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals
Description	Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours)

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg	Part 2: Placebo
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	2
Mean (Standard Deviation); Unit of Measure: Milliseconds
PR Interval- Baseline (Day 1)	156.8 (33.02)	162.9 (29.73)	162.8 (20.83)	144.3 (6.13)
PR Interval- Day 7: Pre-dose	166.5 (25.62)	161.8 (31.06)	155.5 (26.10)	137.0 (5.66)
PR Interval- Day 7: 2 hours	162.8 (28.34)	160.5 (28.73)	159.7 (26.04)	150.5 (3.54)
PR Interval- Day 7: 4 hours	162.0 (24.85)	164.0 (31.51)	154.5 (20.51)	149.0 (11.31)
PR Interval- Day 7: 6 hours	160.7 (24.81)	160.7 (27.25)	160.7 (25.90)	136.5 (3.54)
QRS Duration- Baseline (Day 1)	92.6 (10.22)	95.1 (21.97)	88.9 (7.40)	85.7 (11.31)
QRS Duration- Day 7: Pre-dose	96.5 (8.14)	98.3 (28.86)	88.5 (3.99)	88.0 (4.24)
QRS Duration- Day 7: 2 hours	95.0 (9.78)	95.8 (19.29)	88.8 (4.49)	90.0 (12.73)
QRS Duration- Day 7: 4 hours	94.3 (8.89)	95.2 (18.94)	85.8 (4.88)	89.5 (7.78)
QRS Duration- Day 7: 6 hours	93.2 (10.61)	95.0 (21.29)	88.2 (8.11)	88.5 (17.68)
QT Interval- Baseline (Day 1)	386.6 (28.86)	355.9 (25.37)	362.5 (19.45)	378.8 (1.18)
QT Interval- Day 7: Pre-dose	379.2 (33.30)	354.3 (31.94)	367.5 (26.93)	382.0 (1.41)
QT Interval- Day 7: 2 hours	362.2 (31.24)	351.5 (25.05)	364.3 (17.32)	378.5 (4.95)
QT Interval- Day 7: 4 hours	373.8 (24.25)	360.2 (23.07)	360.8 (18.64)	390.0 (18.38)
QT Interval- Day 7: 6 hours	365.2 (34.53)	361.8 (25.88)	363.2 (19.50)	381.5 (6.36)
QTcB Interval- Baseline (Day 1)	402.88 (26.814)	398.24 (25.587)	411.18 (15.858)	406.73 (20.742)
QTcB Interval- Day 7: Pre-dose	398.72 (26.663)	398.58 (21.075)	414.63 (17.816)	399.65 (18.173)
QTcB Interval- Day 7: 2 hours	405.78 (10.923)	398.33 (33.672)	406.30 (27.565)	388.50 (17.819)
QTcB Interval- Day 7: 4 hours	395.92 (22.851)	397.68 (20.635)	412.48 (27.377)	382.90 (17.961)
QTcB Interval- Day 7: 6 hours	399.62 (19.074)	402.42 (22.916)	409.50 (19.009)	396.90 (3.253)
QTcF Interval- Baseline (Day 1)	397.4 (24.60)	383.5 (23.72)	394.1 (12.71)	397.3 (13.67)
QTcF Interval- Day 7: Pre-dose	391.5 (24.01)	383.0 (24.90)	398.2 (18.58)	394.0 (12.73)
QTcF Interval- Day 7: 2 hours	390.2 (12.16)	382.2 (30.20)	391.8 (22.44)	385.0 (14.14)
QTcF Interval- Day 7: 4 hours	388.0 (18.21)	384.7 (20.42)	394.7 (18.91)	385.0 (18.38)
QTcF Interval- Day 7: 6 hours	387.8 (11.29)	388.0 (21.76)	393.3 (17.20)	391.5 (4.95)

81. Secondary Outcome

Title	Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population consisted of all participants who received GSK3640254 and underwent plasma PK sampling during the study.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	5	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
	0.6946; (13.5%)	12.3929; (91.3%)

82. Secondary Outcome

Title	Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.0591; (177.4%)	0.9381; (82.3%)

83. Secondary Outcome

Title	Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Median (Full Range); Unit of Measure: Hours
	2.9250; (0.000 to 5.000)	5.5250; (3.917 to 8.050)

84. Secondary Outcome

Title	Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.0180; (27.5%)	0.3553; (92.7%)

85. Secondary Outcome

Title	Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Median (Full Range); Unit of Measure: Hours
	0.500; (0.00 to 1.00)	0.000; (0.00 to 1.00)

86. Secondary Outcome

Title	Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
	3.2527; (31.7%)	6.1228; (38.8%)	14.0335; (36.6%)

87. Secondary Outcome

Title	Part 2: Cmax Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.2316; (30.5%)	0.4329; (33.6%)	0.9178; (41.5%)

88. Secondary Outcome

Title	Part 2: Tmax Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Median (Full Range); Unit of Measure: Hours
	4.4167; (3.967 to 8.000)	4.0750; (2.950 to 6.167)	5.5083; (3.000 to 6.250)

89. Secondary Outcome

Title	Part 2: C24 Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.0951; (33.7%)	0.1856; (36.2%)	0.4207; (33.8%)

90. Secondary Outcome

Title	Part 2: Tlag Following Administration of GSK3640254 on Day 1
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Median (Full Range); Unit of Measure: Hours
	0.483; (0.00 to 2.00)	0.000; (0.00 to 1.00)	0.000; (0.00 to 1.00)

91. Secondary Outcome

Title	Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
	0.9082; (44.7%)	27.9363; (18.4%)

92. Secondary Outcome

Title	Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.0549; (41.3%)	1.8559; (19.5%)

93. Secondary Outcome

Title	Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Median (Full Range); Unit of Measure: Hours
	4.0167; (1.867 to 5.000)	5.4833; (3.000 to 6.200)

94. Secondary Outcome

Title	Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	5
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.0268; (41.6%)	0.6928; (33.6%)

95. Secondary Outcome

Title	Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.0267; (47.0%)	0.7033; (29.6%)

96. Secondary Outcome

Title	Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Median (Full Range); Unit of Measure: Hours
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

t1/2 could not be calculated as the criteria of a span ratio [ratio of half-life to time used for half-life calculation] for at least 2 participants could not be fulfilled due to lack of available data.

97. Secondary Outcome

Title	Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:	Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Milliliter per hour
	11010.5393; (44.7%)	7159.1443; (18.4%)

98. Secondary Outcome

Title	Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Hours*microgram per milliliter
	7.4626; (26.8%)	11.8256; (26.7%)	29.2952; (27.9%)

99. Secondary Outcome

Title	Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.4692; (20.6%)	0.7470; (23.7%)	1.8574; (26.0%)

100. Secondary Outcome

Title	Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Median (Full Range); Unit of Measure: Hours
	4.0583; (2.000 to 8.000)	4.5750; (4.000 to 5.183)	4.0750; (2.917 to 5.200)

101. Secondary Outcome

Title	Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.2155; (24.2%)	0.3575; (38.0%)	0.7520; (38.8%)

102. Secondary Outcome

Title	Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Microgram per milliliter
	0.2187; (30.1%)	0.3599; (31.1%)	0.7979; (34.1%)

103. Secondary Outcome

Title	Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Median (Full Range); Unit of Measure: Hours
	NA [1]; (NA to NA)	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

t1/2 could not be calculated as the criteria of a span ratio [ratio of half-life to time used for half-life calculation] for at least 2 participants could not be fulfilled due to lack of available data.

104. Secondary Outcome

Title	Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Milliliter per hour
	5360.0526; (26.8%)	6764.9862; (26.7%)	4778.9430; (27.9%)

105. Secondary Outcome

Title	Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau)
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (AUC) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). PK/PD Population consisted of participants who met criteria for Per-Protocol and Pharmacokinetic Population analysis sets and who underwent PD sampling during the study.
Time Frame	Baseline (Day 1) and Day 8

Outcome Measure Data

Analysis Population Description

PK/PD Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	6	6
Mean (Standard Deviation); Unit of Measure: Copies per milliliter
	12071.4 (42117.29)	-113331.4 (89475.00)	-48655.0 (26269.41)	-37904.3 (38814.54)	-64861.5 (83728.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Emax
	Estimated Value	-1.937
	Confidence Interval	(2-Sided) 95%; -2.484 to -1.389
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	EC50
	Estimated Value	7.094
	Confidence Interval	(2-Sided) 95%; 0.585 to 13.602
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	s2e
	Estimated Value	0.137
	Confidence Interval	(2-Sided) 95%; 0.062 to 0.212
	Estimation Comments	[Not Specified]

106. Secondary Outcome

Title	Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Cmax) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e.
Time Frame	Baseline (Day 1) and Day 8

Outcome Measure Data

Analysis Population Description

PK/PD Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	6	6
Mean (Standard Deviation); Unit of Measure: Copies per milliliter
	12071.4 (42117.29)	-113331.4 (89475.00)	-48655.0 (26269.41)	-37904.3 (38814.54)	-64861.5 (83728.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Emax
	Estimated Value	-1.929
	Confidence Interval	(2-Sided) 95%; -2.479 to -1.379
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	EC50
	Estimated Value	0.446
	Confidence Interval	(2-Sided) 95%; 0.030 to 0.861
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	s2e
	Estimated Value	0.139
	Confidence Interval	(2-Sided) 95%; 0.063 to 0.216
	Estimation Comments	[Not Specified]

107. Secondary Outcome

Title	Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Ctau) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e.
Time Frame	Baseline (Day 1) and Day 8

Outcome Measure Data

Analysis Population Description

PK/PD Population.

Arm/Group Title	Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6	6	6
Mean (Standard Deviation); Unit of Measure: Copies per milliliter
	12071.4 (42117.29)	-113331.4 (89475.00)	-48655.0 (26269.41)	-37904.3 (38814.54)	-64861.5 (83728.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Emax
	Estimated Value	-1.926
	Confidence Interval	(2-Sided) 95%; -2.498 to -1.354
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	EC50
	Estimated Value	0.197
	Confidence Interval	(2-Sided) 95%; 0.007 to 0.386
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part 1: GSK3640254 10 mg, Part 1: GSK3640254 200 mg, Part 2: GSK3640254 40 mg, Part 2: GSK3640254 80 mg, Part 2: GSK3640254 140 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	s2e
	Estimated Value	0.144
	Confidence Interval	(2-Sided) 95%; 0.065 to 0.222
	Estimation Comments	[Not Specified]

108. Secondary Outcome

Title	Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro_AUC equal to (=) AUC(0-tau) Days 8 to 10 divided by (/) AUC(0-24) Day 1; Ro_Cmax=Cmax Days 8 to 10/Cmax Day 1; and Ro_Ctau=Ctau Days 8 to 10/C24 Day 1.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title		Part 1: GSK3640254 10 mg	Part 1: GSK3640254 200 mg
Arm/Group Description:		Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.
Overall Number of Participants Analyzed		6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Ratio
Ro_AUC(0-tau), n=5,6	Number Analyzed	5 participants	6 participants
		1.5352; (24.5%)	2.2542; (72.1%)
Ro_Cmax, n=6,6	Number Analyzed	6 participants	6 participants
		0.9287; (171.7%)	1.9785; (69.4%)
Ro_Ctau, n=6,6	Number Analyzed	6 participants	6 participants
		1.4790; (22.2%)	1.9796; (61.2%)

109. Secondary Outcome

Title	Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro_AUC=AUC(0-tau) Day 7/AUC(0-24) Day 1; Ro_Cmax=Cmax Day 7/Cmax Day 1; and Ro_Ctau=Ctau Day 7/C24 Day 1.
Time Frame	Days 1 and 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	Part 2: GSK3640254 40 mg	Part 2: GSK3640254 80 mg	Part 2: GSK3640254 140 mg
Arm/Group Description:	Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Overall Number of Participants Analyzed	6	6	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Ratio
Ro_AUC(0-tau)	2.2943; (11.2%)	1.9314; (18.6%)	2.0875; (29.2%)
Ro_Cmax	2.0258; (24.4%)	1.7258; (17.6%)	2.0236; (37.5%)
Ro_Ctau	2.2985; (6.4%)	1.9389; (20.8%)	1.8967; (16.0%)

110. Secondary Outcome

Title	Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	GSK3640254 10 mg to 200 mg
Arm/Group Description:	In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Slope of log dose
	1.018; (0.876 to 1.160)

111. Secondary Outcome

Title	Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	GSK3640254 10 mg to 200 mg
Arm/Group Description:	In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Slope of log dose
	0.964; (0.774 to 1.154)

112. Secondary Outcome

Title	Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time Frame	Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	GSK3640254 10 mg to 200 mg
Arm/Group Description:	In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Slope of log dose
	1.061; (0.924 to 1.199)

113. Secondary Outcome

Title	Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau)
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	GSK3640254 10 mg to 200 mg
Arm/Group Description:	In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Slope of log dose
	1.179; (1.074 to 1.283)

114. Secondary Outcome

Title	Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	GSK3640254 10 mg to 200 mg
Arm/Group Description:	In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Slope of log dose
	1.204; (1.107 to 1.302)

115. Secondary Outcome

Title	Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time Frame	Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population.

Arm/Group Title	GSK3640254 10 mg to 200 mg
Arm/Group Description:	In Part 1, participants received GSK3640254 10 mg, 200 mg, capsules, orally for 10 days and in Part 2, participants received GSK3640254 40 mg, 80 mg, 140 mg, capsules, orally for 7 days.
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Slope of log dose
	1.137; (1.018 to 1.257)

Adverse Events

Time Frame

Part 1: up to Day 24; Part 2: up to Day 12

Adverse Event Reporting Description

Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.

Arm/Group Title

Part 1: GSK3640254 10 mg

Part 1: GSK3640254 200 mg

Part 1: Placebo

Part 2: GSK3640254 40 mg

Part 2: GSK3640254 80 mg

Part 2: GSK3640254 140 mg

Part 2: Placebo

Arm/Group Description

Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.

Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.

Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.

Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.

Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.

Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.

Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.

All-Cause Mortality

Part 1: GSK3640254 10 mg

Part 1: GSK3640254 200 mg

Part 1: Placebo

Part 2: GSK3640254 40 mg

Part 2: GSK3640254 80 mg

Part 2: GSK3640254 140 mg

Part 2: Placebo

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/6 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/6 (0.00%)

0/6 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

Serious Adverse Events

Part 1: GSK3640254 10 mg

Part 1: GSK3640254 200 mg

Part 1: Placebo

Part 2: GSK3640254 40 mg

Part 2: GSK3640254 80 mg

Part 2: GSK3640254 140 mg

Part 2: Placebo

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

1/6 (16.67%)

0/6 (0.00%)

0/2 (0.00%)

0/6 (0.00%)

0/6 (0.00%)

1/6 (16.67%)

0/2 (0.00%)

Cardiac disorders

Congestive cardiomyopathy † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Infections and infestations

Anal abscess † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

5%

Part 1: GSK3640254 10 mg

Part 1: GSK3640254 200 mg

Part 1: Placebo

Part 2: GSK3640254 40 mg

Part 2: GSK3640254 80 mg

Part 2: GSK3640254 140 mg

Part 2: Placebo

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

3/6 (50.00%)

5/6 (83.33%)

0/2 (0.00%)

5/6 (83.33%)

4/6 (66.67%)

4/6 (66.67%)

0/2 (0.00%)

Blood and lymphatic system disorders

Lymphadenopathy † 1

1/6 (16.67%)

1

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Neutropenia † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

Cardiac disorders

Myocarditis † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Gastrointestinal disorders

Diarrhoea † 1

1/6 (16.67%)

1

1/6 (16.67%)

1

0/2 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Abdominal pain † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

2/6 (33.33%)

3

0/6 (0.00%)

0

0/2 (0.00%)

0

Vomiting † 1

1/6 (16.67%)

1

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Constipation † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

Nausea † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

General disorders

Asthenia † 1

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Fatigue † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

1/6 (16.67%)

2

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Nodule † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

Pyrexia † 1

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Infections and infestations

Nasopharyngitis † 1

0/6 (0.00%)

0

2/6 (33.33%)

2

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Meningococcal infection † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Pharyngitis † 1

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Upper respiratory tract infection † 1

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Urinary tract infection † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

Viral infection † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Investigations

Alanine aminotransferase increased † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Aspartate aminotransferase increased † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Metabolism and nutrition disorders

Hyperglycaemia † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Insulin resistance † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Vitamin D deficiency † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Musculoskeletal and connective tissue disorders

Pain in extremity † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

Spinal pain † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Nervous system disorders

Headache † 1

0/6 (0.00%)

0

2/6 (33.33%)

2

0/2 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

Migraine † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

Presyncope † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Renal and urinary disorders

Chromaturia † 1

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain † 1

0/6 (0.00%)

0

2/6 (33.33%)

2

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

Catarrh † 1

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Epistaxis † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

Skin and subcutaneous tissue disorders

Dermatitis atopic † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/6 (0.00%)

0

0/2 (0.00%)

0

Pruritus † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

Rash maculo-papular † 1

0/6 (0.00%)

0

0/6 (0.00%)

0

0/2 (0.00%)

0

0/6 (0.00%)

0

0/6 (0.00%)

0

1/6 (16.67%)

1

0/2 (0.00%)

0

1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: ViiV Healthcare
• Phone: 866-435-7343
• EMail: GSKClinicalSupportHD@gsk.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Spinner CD, Felizarta F, Rizzardini G, Philibert P, Mitha E, Domingo P, Stephan CJ, DeGrosky M, Bainbridge V, Zhan J, Dumitrescu TP, Jeffrey JL, Xu J, Halliday F, Gan J, Johnson M, Gartland M, Joshi SR, Lataillade M. Phase IIa Proof-of-Concept Evaluation of the Antiviral Efficacy, Safety, Tolerability, and Pharmacokinetics of the Next-Generation Maturation Inhibitor GSK3640254. Clin Infect Dis. 2022 Sep 14;75(5):786-794. doi: 10.1093/cid/ciab1065.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT03784079
• Other Study ID Numbers: 208132
• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Results First Submitted: January 27, 2021
• Results First Posted: February 16, 2021
• Last Update Posted: February 16, 2021