Trial record 1 of 1 for: NCT04091061

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Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04091061

Recruitment Status : Completed

First Posted : September 16, 2019

Results First Posted : April 13, 2021

Last Update Posted : April 13, 2021

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Sponsor:

Information provided by (Responsible Party):

Pfizer

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Conditions	Hepatic Impairment Healthy Volunteers
Intervention	Drug: PF-06865571 100 mg
Enrollment	24

Participant Flow

Recruitment Details
Pre-assignment Details	Of the 32 participants screened for entry into the study, 24 participants were assigned and received a single, oral 100 mg dose of PF-06865571: 6 participants in each of the 4 hepatic function cohorts.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Period Title: Overall Study
Started	6	6	6	6
Completed	6	6	6	6
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)	Total
Arm/Group Description		Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Total of all reporting groups
Arm/Group Description		Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.	Total of all reporting groups
Overall Number of Baseline Participants		6	6	6	6	24
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	6 participants	6 participants	6 participants	6 participants	24 participants
		60.8 (3.92)	58.2 (5.15)	64.5 (5.32)	57.5 (8.60)	60.3 (6.26)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	6 participants	6 participants	24 participants
	Female	4 66.7%	3 50.0%	0 0.0%	3 50.0%	10 41.7%
	Male	2 33.3%	3 50.0%	6 100.0%	3 50.0%	14 58.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	6 participants	6 participants	24 participants
	Hispanic or Latino	4 66.7%	4 66.7%	3 50.0%	3 50.0%	14 58.3%
	Not Hispanic or Latino	2 33.3%	2 33.3%	3 50.0%	3 50.0%	10 41.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	6 participants	6 participants	24 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	2 33.3%	2 8.3%
	White	6 100.0%	6 100.0%	6 100.0%	4 66.7%	22 91.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Maximum Observed Plasma Concentration (Cmax)
Description	Cmax of PF-06865571 was observed directly from data.
Description	Cmax of PF-06865571 was observed directly from data.
Time Frame	For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.

Outcome Measure Data

Analysis Population Description

All participants who received PF-06865571 and in whom at least 1 plasma concentration value was reported.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: nanogram per milliliter (ng/mL)
	532.2 (153%)	835.5 (39%)	668.3 (35%)	658.6 (42%)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 2 (Mild Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% Confidence Intervals (CIs) for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	156.99
	Confidence Interval	(2-Sided) 90% 83.14 to 296.44
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 3 (Moderate Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	125.58
	Confidence Interval	(2-Sided) 90% 66.51 to 237.13
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 4 (Severe Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	123.75
	Confidence Interval	(2-Sided) 90% 65.54 to 233.68
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference

2.Primary Outcome


Title	Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
Description	AUClast of PF-06865571 was determined by linear/log trapezoidal method...
Description	AUClast of PF-06865571 was determined by linear/log trapezoidal method.
Time Frame	For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.

Outcome Measure Data

Analysis Population Description

All participants dosed who had at least 1 of the PK parameters.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: nanogramhour per milliliter (nghr/mL)
	2078 (155%)	3247 (40%)	3443 (42%)	3163 (47%)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 2 (Mild Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	156.25
	Confidence Interval	(2-Sided) 90% 81.07 to 301.16
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 3 (Moderate Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	165.66
	Confidence Interval	(2-Sided) 90% 85.95 to 319.29
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 4 (Severe Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	152.18
	Confidence Interval	(2-Sided) 90% 78.96 to 293.32
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference

3.Primary Outcome


Title	Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
Description	AUCinf = Area under the plasma concentration versus time curve (AUC) f...
Description	AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
Time Frame	For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.

Outcome Measure Data

Analysis Population Description

All participants dosed who had at least 1 of the PK parameters.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: ng*hr/mL
	2083 (155%)	3250 (39%)	3445 (42%)	3171 (47%)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 2 (Mild Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	156.00
	Confidence Interval	(2-Sided) 90% 80.95 to 300.60
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 3 (Moderate Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	165.38
	Confidence Interval	(2-Sided) 90% 85.82 to 318.67
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cohort 1 (Without Hepatic Impairment), Cohort 4 (Severe Hepatic Impairment)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference

Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	152.20
	Confidence Interval	(2-Sided) 90% 78.99 to 293.29
	Estimation Comments	90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference

4.Secondary Outcome


Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	An adverse event (AE) was any untoward medical occurrence attributed t...
Description	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who receives study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events following start of treatment.
Time Frame	Up to Day 32 (31 days after investigational product administration)

Outcome Measure Data

Analysis Population Description

All participants who received PF-06865571.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed	6	6	6	6
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%

5.Secondary Outcome


Title	Number of Participants With Clinical Laboratory Abnormalities
Description	The following parameters were analyzed for laboratory examination: hem...
Description	The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.
Time Frame	Up to Day 4 (3 days after investigational product administration)

Outcome Measure Data

Analysis Population Description

All participants who received PF-06865571.


Arm/Group Title		Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:		Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:		Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed		6	6	6	6
Measure Type: Count of Participants Unit of Measure: Participants
Hemoglobin <0.8xLower limit of normal (LLN)	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Hemoglobin <0.8xLower limit of normal (LLN)		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Hematocrit <0.8xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Hematocrit <0.8xLLN		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Erythrocytes (Ery.) <0.8xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Erythrocytes (Ery.) <0.8xLLN		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Ery. Mean Corpuscular Volume <0.9xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Ery. Mean Corpuscular Volume <0.9xLLN		0 0.0%	1 16.7%	0 0.0%	0 0.0%
Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN)	Number Analyzed	6 participants	6 participants	6 participants	6 participants
		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Ery. Mean Corpuscular Hemoglobin <0.9xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Ery. Mean Corpuscular Hemoglobin <0.9xLLN		0 0.0%	1 16.7%	0 0.0%	0 0.0%
Ery. Mean Corpuscular Hemoglobin >1.1xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Ery. Mean Corpuscular Hemoglobin >1.1xULN		0 0.0%	0 0.0%	0 0.0%	2 33.3%
Platelets <0.5xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Platelets <0.5xLLN		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Leukocytes <0.6xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Leukocytes <0.6xLLN		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Lymphocytes <0.8xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Lymphocytes <0.8xLLN		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Neutrophils <0.8xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Neutrophils <0.8xLLN		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Monocytes >1.2xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Monocytes >1.2xULN		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Activated Partial Thromboplastin Time >1.1xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Activated Partial Thromboplastin Time >1.1xULN		1 16.7%	1 16.7%	2 33.3%	2 33.3%
Prothrombin Time >1.1xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Prothrombin Time >1.1xULN		0 0.0%	0 0.0%	0 0.0%	3 50.0%
Prothrombin International. Normalized Ratio >1.1xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Prothrombin International. Normalized Ratio >1.1xULN		0 0.0%	0 0.0%	0 0.0%	3 50.0%
Bilirubin >1.5xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Bilirubin >1.5xULN		0 0.0%	0 0.0%	1 16.7%	4 66.7%
Direct Bilirubin >1.5xULN	Number Analyzed	0 participants	0 participants	2 participants	4 participants
Direct Bilirubin >1.5xULN		0	0	1 50.0%	4 100.0%
Indirect Bilirubin >1.5xULN	Number Analyzed	0 participants	0 participants	2 participants	4 participants
Indirect Bilirubin >1.5xULN		0	0	0 0.0%	1 25.0%
Aspartate Aminotransferase >3.0xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Aspartate Aminotransferase >3.0xULN		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Alanine Aminotransferase >3.0xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Alanine Aminotransferase >3.0xULN		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Gamma Glutamyl Transferase >3.0xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Gamma Glutamyl Transferase >3.0xULN		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Albumin <0.8xLLN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Albumin <0.8xLLN		0 0.0%	0 0.0%	1 16.7%	1 16.7%
Glucose >1.5xULN	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Glucose >1.5xULN		0 0.0%	2 33.3%	1 16.7%	0 0.0%
Urine Glucose ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Glucose ≥1		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Urine Ketones ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Ketones ≥1		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Urine Protein ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Protein ≥1		0 0.0%	0 0.0%	0 0.0%	1 16.7%
Urine Hemoglobin ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Hemoglobin ≥1		2 33.3%	1 16.7%	2 33.3%	0 0.0%
Urine Urobilinogen ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Urobilinogen ≥1		0 0.0%	0 0.0%	1 16.7%	2 33.3%
Urine Bilirubin ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Bilirubin ≥1		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Urine Nitrite ≥1	Number Analyzed	6 participants	6 participants	6 participants	6 participants
Urine Nitrite ≥1		0 0.0%	0 0.0%	1 16.7%	0 0.0%
Urine Leukocytes ≥20	Number Analyzed	3 participants	3 participants	3 participants	1 participants
Urine Leukocytes ≥20		0 0.0%	1 33.3%	1 33.3%	0 0.0%
Urine Bacteria >20	Number Analyzed	3 participants	3 participants	3 participants	1 participants
Urine Bacteria >20		0 0.0%	1 33.3%	0 0.0%	0 0.0%

6.Secondary Outcome


Title	Number of Participants With Categorical Vital Signs Data
Description	Vital signs (systolic and diastolic blood pressure, and pulse rate) we...
Description	Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.
Time Frame	Up to Day 4 (3 days after investigational product administration)

Outcome Measure Data

Analysis Population Description

All participants who received PF-06865571.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed	6	6	6	6
Measure Type: Count of Participants Unit of Measure: Participants
Systolic Blood Pressure (mmHg) Value <90 mmHg	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Systolic Blood Pressure (mmHg) Change >=30 mmHg increase	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Diastolic Blood Pressure (mmHg) Value <50 mmHg	0 0.0%	0 0.0%	1 16.7%	1 16.7%
Diastolic Blood Pressure (mmHg) Change >=20 mmHg increase	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease	0 0.0%	0 0.0%	1 16.7%	0 0.0%
Pulse Rate (beats per minute [bpm]) Value <40 bpm	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Pulse Rate (bpm) Value >120 bpm	0 0.0%	0 0.0%	0 0.0%	0 0.0%

7.Secondary Outcome


Title	Number of Participants With Categorical Electrocardiogram (ECG)
Description	QT interval corrected using Fridericia's formula (QTcF) was obtained w...
Description	QT interval corrected using Fridericia's formula (QTcF) was obtained with participants. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position.
Time Frame	Up to Day 4 (3 days after investigational product administration)

Outcome Measure Data

Analysis Population Description

All participants who received PF-06865571.


Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description:	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description:	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
Overall Number of Participants Analyzed	6	6	6	6
Measure Type: Count of Participants Unit of Measure: Participants
QTcF (millisecond [msec]) 450< Value <=480	0 0.0%	0 0.0%	1 16.7%	1 16.7%
QTcF (msec) 480< Value <=500	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QTcF (msec) Value >500	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QTcF (msec) 30<= Change <=60	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QTcF (msec) Change >60	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	Up to Day 32 (31 days after investigational product administration)
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
Arm/Group Description	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...	Hepatic function was categorized ba...
Arm/Group Description	Hepatic function was categorized based on Child Pugh Score. NA for participants without hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class A (5 to 6 points) for participants with mild hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class B (7 to 9 points) for participants with moderate hepatic impairment.	Hepatic function was categorized based on Child Pugh Score. Class C (10 to 15 points) for participants with severe hepatic impairment.
All-Cause Mortality
	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)
Serious Adverse Events Serious Adverse Events
	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cohort 1 (Without Hepatic Impairment)	Cohort 2 (Mild Hepatic Impairment)	Cohort 3 (Moderate Hepatic Impairment)	Cohort 4 (Severe Hepatic Impairment)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)

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.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Pfizer ClinicalTrials.gov Call Center
Organization:	Pfizer Inc.
Phone:	1-800-718-1021
EMail:	ClinicalTrials.gov_Inquiries@pfizer.com

Layout table for additonal information

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT04091061
Other Study ID Numbers:	C2541009
First Submitted:	September 13, 2019
First Posted:	September 16, 2019
Results First Submitted:	March 18, 2021
Results First Posted:	April 13, 2021
Last Update Posted:	April 13, 2021

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