- Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 24 ]
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.
- Part 2: Number of Participants With Non-SAEs and SAEs [ Time Frame: Up to Day 12 ]
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.
- Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Hematology Parameter: Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Hematology Parameter: Hematocrit [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Hematology Parameter: Erythrocytes [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Hematology Parameter: Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Hematology Parameter: Hematocrit [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Hematology Parameter: Erythrocytes [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- 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 [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Chemistry Parameters: Protein [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase [ Time Frame: Baseline (Day 1) and Visit 6 (Day 11) ]
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.
- Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Chemistry Parameters: Protein [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Urinalysis Parameter: pH [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Respiratory Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Change From Baseline in Pulse Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 2: Change From Baseline in SBP and DBP [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Respiratory Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Change From Baseline in Pulse Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- 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) [ Time Frame: Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours) ]
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.
- Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF [ Time Frame: Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours) ]
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.
- Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Hematology Parameter: Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Hematology Parameter: Hematocrit [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Hematology Parameter: Erythrocytes [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Hematology Parameter: Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Hematology Parameter: Hematocrit [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Hematology Parameter: Erythrocytes [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Chemistry Parameters: Protein [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase [ Time Frame: Baseline (Day 1) and Visit 6 (Day 11) ]
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.
- Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Chemistry Parameters: Protein [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Urinalysis Parameter: pH [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Urinalysis Parameter: pH [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 1: Absolute Values for SBP and DBP [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Respiratory Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 1: Absolute Values for Pulse Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Days 8 to 10) ]
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.
- Part 2: Absolute Values for SBP and DBP [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Respiratory Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 2: Absolute Values for Pulse Rate [ Time Frame: Baseline (Day 1) and Visit 5 (Day 7) ]
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.
- Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals [ Time Frame: Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours) ]
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.
- Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals [ Time Frame: Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours) ]
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.
- Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
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.
- Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: Cmax Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: Tmax Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: C24 Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: Tlag Following Administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- 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 [ Time Frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 [ Time Frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 [ Time Frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 [ Time Frame: Days 8 to 10: Pre-dose ]
Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 [ Time Frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 [ Time Frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 [ Time Frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose ]
Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7 [ Time Frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
- Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) [ Time Frame: Baseline (Day 1) and Day 8 ]
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.
- Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax [ Time Frame: Baseline (Day 1) and Day 8 ]
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.
- Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau [ Time Frame: Baseline (Day 1) and Day 8 ]
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.
- Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 [ 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 ]
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.
- Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 [ Time Frame: Days 1 and 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
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.
- Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24) [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
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.
- Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
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.
- Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose ]
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.
- Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau) [ 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 ]
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.
- Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax [ 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 ]
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.
- Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau [ 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 ]
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.
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- Part 1: Number of subjects with adverse events and serious adverse events [ Time Frame: Up to Day 24 ]
An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious adverse event is defined as any untoward medical occurrence that, at any dose that 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.
- Part 2: Number of subjects with adverse events and serious adverse events [ Time Frame: Up to Day 24 ]
An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious adverse event is defined as any untoward medical occurrence that, at any dose that 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.
- Part 1: Number of subjects with abnormal findings for hematology parameters [ Time Frame: Up to Day 24 ]
Blood samples will be collected from subjects for analysis of hematology parameters including platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percent reticulocytes, white blood cells (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, red blood cells (RBC) count, hemoglobin and hematocrit.
- Part 2: Number of subjects with abnormal findings for hematology parameters [ Time Frame: Up to Day 24 ]
Blood samples will be collected from subjects for analysis of hematology parameters including platelet count, MCV, MCH, percent reticulocytes, WBC count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, RBC count, hemoglobin and hematocrit.
- Part 1: Number of subjects with abnormal findings for clinical chemistry parameters [ Time Frame: Up to Day 24 ]
Blood samples will be collected from subjects for analysis of clinical chemistry parameters including blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine sodium bicarbonate, chloride, alanine aminotransferase (ALT), total protein, glucose (nonfasting), calcium, magnesium, phosphate, alkaline phosphatase, cholesterol, triglycerides, high density lipoprotein (HDL), and low density lipoprotein (LDL).
- Part 2: Number of subjects with abnormal findings for clinical chemistry parameters [ Time Frame: Up to Day 24 ]
Blood samples will be collected from subjects for analysis of clinical chemistry parameters including BUN, potassium, AST, total bilirubin, direct bilirubin, creatinine sodium bicarbonate, chloride, ALT, total protein, glucose (nonfasting), calcium, magnesium, phosphate, alkaline phosphatase, cholesterol, triglycerides, HDL, and LDL.
- Part 1: Number of subjects with abnormal findings for urinalysis parameters [ Time Frame: Up to Day 24 ]
Urine samples will be collected from subjects for analysis of specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine by dipstick test. Microscopic examination will be performed if blood or protein is abnormal.
- Part 2: Number of subjects with abnormal findings for urinalysis parameters [ Time Frame: Up to Day 24 ]
Urine samples will be collected from subjects for analysis of specific gravity, pH of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine by dipstick test. Microscopic examination will be performed if blood or protein is abnormal.
- Part 1: Number of subjects with abnormal values for blood pressure [ Time Frame: Up to Day 24 ]
Systolic and diastolic blood pressure of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
- Part 2: Number of subjects with abnormal values for blood pressure [ Time Frame: Up to Day 24 ]
Systolic and diastolic blood pressure of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
- Part 1: Number of subjects with abnormal values for respiratory rate [ Time Frame: Up to Day 24 ]
Respiratory rate of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
- Part 2: Number of subjects with abnormal values for respiratory rate [ Time Frame: Up to Day 24 ]
Respiratory rate of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
- Part 1: Number of subjects with abnormal values for pulse rate [ Time Frame: Up to Day 24 ]
Pulse rate of subjects will be measured in a semi-supine or supine position after at least 5 minutes of rest.
- Part 2: Number of subjects with abnormal values for pulse rate [ Time Frame: Up to Day 24 ]
Pulse rate of subjects will be measured in a semi-supine or supine position after at least 5 minutes of rest.
- Part 1: Number of subjects with abnormal values for electrocardiogram parameters [ Time Frame: Up to Day 24 ]
Single 12-lead electrocardiogram will be obtained using an electrocardiogram machine.
- Part 2: Number of subjects with abnormal values for electrocardiogram parameters [ Time Frame: Up to Day 24 ]
Single 12-lead electrocardiogram will be obtained using an electrocardiogram machine.
- Part 1: Area under the plasma concentration time curve from zero to 24 (AUC [0-24]) following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: AUC (0-24) following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Maximum observed concentration (Cmax) following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: Cmax following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Time to maximum observed concentration (Tmax) following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: Tmax following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Concentration at 24 hours post-dose (C24) following administration of GSK3640254 on Day 1 [ Time Frame: 24 hours post-dose on Day 1 ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: C24 following administration of GSK3640254 on Day 1 [ Time Frame: 24 hours post-dose on Day 1 ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Absorption lag time (Tlag) following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: Tlag following administration of GSK3640254 on Day 1 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- 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 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: AUC (0-tau) following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Cmax following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: Cmax following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Tmax following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: Tmax following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Concentration (C0) following repeat dose administration of GSK3640254 [ Time Frame: Pre-dose on Day 1, Day 3 or 4, Day 5 or 6 or 7; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17 ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: C0 following repeat dose administration of GSK3640254 [ Time Frame: Pre-dose on Day 1, Day 3 or 4, Day 5 or 6 or 7; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17 ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Concentration at end of dosing interval (Ctau) following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: Ctau following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Apparent terminal phase half-life (t1/2) following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: T1/2 following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: Apparent oral clearance (CL/F) following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 2: CL/F following repeat dose administration of GSK3640254 [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Blood samples will be collected for pharmacokinetic analysis of GSK3640254.
- Part 1: AUC (0-tau) of GSK3640254 with respect to change from Baseline in HIV-1 RNA [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Relationships between pharmacokinetic and pharmacodynamics parameters will be explored following administration of GSK3640254
- Part 2: AUC (0-tau) of GSK3640254 with respect to change from Baseline in HIV-1 RNA [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Relationships between pharmacokinetic and pharmacodynamics parameters will be explored following administration of GSK3640254.
- Part 1:Cmax of GSK3640254 with respect to change from Baseline in HIV-1 RNA [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Relationships between pharmacokinetic and pharmacodynamics parameters will be explored following administration of GSK3640254.
- Part 2: Cmax of GSK3640254 with respect to change from Baseline in HIV-1 RNA [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Relationships between pharmacokinetic and pharmacodynamics parameters will be explored following administration of GSK3640254.
- Part 1: Ctau of GSK3640254 with respect to change from Baseline IN HIV-1 RNA [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Relationships between pharmacokinetic and pharmacodynamics parameters will be explored following administration of GSK3640254.
- Part 2:Ctau of GSK3640254 with respect to change from Baseline in HIV-1 RNA [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Relationships between pharmacokinetic and pharmacodynamics parameters will be explored following administration of GSK3640254.
- Part 1:Accumulation ratio of GSK3640254 following repeat dose by AUC (0-tau) [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Accumulation ratio will be estimated from the ratio of AUC (0-tau) following repeat dose/AUC (0-24) following dosing on Day 1.
- Part 2:Accumulation ratio of GSK3640254 following repeat dose by AUC (0-tau) [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Accumulation ratio will be estimated from the ratio of AUC (0-tau) following repeat dose/AUC (0-24) following dosing on Day 1.
- Part 1: Accumulation ratio of GSK3640254 following repeat dose by Cmax [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Accumulation ratio will be estimated from the ratio of Cmax following repeat dose/Cmax following dosing on Day 1.
- Part 2: Accumulation ratio of GSK3640254 following repeat dose by Cmax [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Accumulation ratio will be estimated from the ratio of Cmax following repeat dose/Cmax following dosing on Day 1.
- Part 1: Accumulation ratio of GSK3640254 following repeat dose by Ctau [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Accumulation ratio will be estimated from the ratio of Ctau following repeat dose/C24 following dosing on Day 1.
- Part 2: Accumulation ratio of GSK3640254 following repeat dose by Ctau [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Accumulation ratio will be estimated from the ratio of Ctau following repeat dose/C24 following dosing on Day 1.
- Part 1: Dose proportionality of GSK3640254 administered on Day 1 based on AUC (0-24) [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the AUC (0-24) following administration of GSK3640254 on Day 1.
- Part 2: Dose proportionality of GSK3640254 administered on Day 1 based on AUC (0-24) [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the AUC (0-24) following administration of GSK3640254 on Day 1.
- Part 1: Dose proportionality of GSK3640254 administered on Day 1 based on Cmax [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the Cmax following administration of GSK3640254 on Day 1.
- Part 2: Dose proportionality of GSK3640254 administered on Day 1 based on Cmax [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the Cmax following administration of GSK3640254 on Day 1.
- Part 1: Dose proportionality of GSK3640254 administered on Day 1 based on C24 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the C24 following administration of GSK3640254 on Day 1.
- Part 2: Dose proportionality of GSK3640254 administered on Day 1 based on C24 [ Time Frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the C24 following administration of GSK3640254 on Day 1.
- Part 1: Dose proportionality of GSK3640254 following repeat dose administration based on AUC (0-tau) [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the AUC (0-tau) following repeat dose administration of GSK3640254.
- Part 2: Dose proportionality of GSK3640254 following repeat dose administration based on AUC (0-tau) [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the AUC (0-tau) following repeat dose administration of GSK3640254.
- Part 1: Dose proportionality of GSK3640254 following repeat dose administration based on Cmax [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the Cmax following repeat dose administration of GSK3640254.
- Part 2: Dose proportionality of GSK3640254 following repeat dose administration based on Cmax [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the Cmax following repeat dose administration of GSK3640254.
- Part 1: Dose proportionality of GSK3640254 following repeat dose administration based on Ctau [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the Ctau following repeat dose administration of GSK3640254.
- Part 2: Dose proportionality of GSK3640254 following repeat dose administration based on Ctau [ Time Frame: Day 1: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose; Day 3 or 4, Day 5 or 6 or 7: Pre-dose; Day 11, Day 12, Day 13 or 14 or 15 or 16 or 17; Day 8 or 9 or 10: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose ]
Dose proportionality will be assessed from the Ctau following repeat dose administration of GSK3640254.
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