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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04091061
• Collaborator: (none)

Study Details

Study Description

Brief Summary

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment; Healthy Volunteers	Drug: PF-06865571 100 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF 06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
• Actual Study Start Date: Oct 3, 2019
• Actual Primary Completion Date: Apr 7, 2020
• Actual Study Completion Date: Apr 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-06865571 Moderate Hepatic Impairment This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1	Drug: PF-06865571 100 mg; PF-06865571 in 100 mg oral tablet will be administered on Day 1
Experimental: PF-06865571 Severe Hepatic Impairment This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1	Drug: PF-06865571 100 mg; PF-06865571 in 100 mg oral tablet will be administered on Day 1
Experimental: PF-06865571 Mild Hepatic Impairment This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1	Drug: PF-06865571 100 mg; PF-06865571 in 100 mg oral tablet will be administered on Day 1
Experimental: PF-06865571 Healthy Participants This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1	Drug: PF-06865571 100 mg; PF-06865571 in 100 mg oral tablet will be administered on Day 1

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) [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.]

   Cmax of PF-06865571 was observed directly from data.

2. Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast) [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.]

   AUClast of PF-06865571 was determined by linear/log trapezoidal method.

3. Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf) [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.]

   AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).

Secondary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Up to Day 32 (31 days after investigational product administration)]

   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.

2. Number of Participants With Clinical Laboratory Abnormalities [Up to Day 4 (3 days after investigational product administration)]

   The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.

3. Number of Participants With Categorical Vital Signs Data [Up to Day 4 (3 days after investigational product administration)]

   Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.

4. Number of Participants With Categorical Electrocardiogram (ECG) [Up to Day 4 (3 days after investigational product administration)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

• Body mass index (BMI) of 17.5 to 35.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the Screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.

• Capable of giving signed informed consent.

Exclusion Criteria

• Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).

• At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed.

• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).

• Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06865571.

• A positive urine drug test, for illicit drugs on Day -1,

• At Screening or Day -1, a positive breath alcohol test.

• Male participants with partners who are currently pregnant.

• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.

• Unwilling or unable to comply with the criteria in the Lifestyle Considerations.

• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Division of Clinical Pharmacology	Miami	Florida	United States	33136
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Jun 27, 2019
• Statistical Analysis Plan - Aug 13, 2019

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04091061
• Other Study ID Numbers: C2541009
• First Posted: Sep 16, 2019
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Non-alcoholic Fatty Liver Disease; Non-alcoholic steatohepatitis
• Additional relevant MeSH terms: Liver Diseases

Study Results

Participant Flow

Pre-assignment Detail	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 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 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 Participants	6	6	6	6	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.8 (3.92)	58.2 (5.15)	64.5 (5.32)	57.5 (8.60)	60.3 (6.26)
Sex: Female, Male (Count of Participants)
Female	4 66.7%	3 50%	0 0%	3 50%	10 41.7%
Male	2 33.3%	3 50%	6 100%	3 50%	14 58.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 66.7%	4 66.7%	3 50%	3 50%	14 58.3%
Not Hispanic or Latino	2 33.3%	2 33.3%	3 50%	3 50%	10 41.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	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%
Black or African American	0 0%	0 0%	0 0%	2 33.3%	2 8.3%
White	6 100%	6 100%	6 100%	4 66.7%	22 91.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	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.
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 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.
Measure Participants	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	156.99
	Confidence Interval	(2-Sided) 90%; 83.14 to 296.44
	Parameter Dispersion	Type: Value:
	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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	125.58
	Confidence Interval	(2-Sided) 90%; 66.51 to 237.13
	Parameter Dispersion	Type: Value:
	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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	123.75
	Confidence Interval	(2-Sided) 90%; 65.54 to 233.68
	Parameter Dispersion	Type: Value:
	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.
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 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.
Measure Participants	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	156.25
	Confidence Interval	(2-Sided) 90%; 81.07 to 301.16
	Parameter Dispersion	Type: Value:
	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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	165.66
	Confidence Interval	(2-Sided) 90%; 85.95 to 319.29
	Parameter Dispersion	Type: Value:
	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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	152.18
	Confidence Interval	(2-Sided) 90%; 78.96 to 293.32
	Parameter Dispersion	Type: Value:
	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) 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 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.
Measure Participants	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	156.00
	Confidence Interval	(2-Sided) 90%; 80.95 to 300.60
	Parameter Dispersion	Type: Value:
	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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	165.38
	Confidence Interval	(2-Sided) 90%; 85.82 to 318.67
	Parameter Dispersion	Type: Value:
	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
	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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio (%)
	Estimated Value	152.20
	Confidence Interval	(2-Sided) 90%; 78.99 to 293.29
	Parameter Dispersion	Type: Value:
	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 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 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.
Measure Participants	6	6	6	6
Count of Participants [Participants]	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: 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 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.
Measure Participants	6	6	6	6
Hemoglobin <0.8xLower limit of normal (LLN)	0 0%	0 0%	0 0%	1 16.7%
Hematocrit <0.8xLLN	0 0%	0 0%	0 0%	1 16.7%
Erythrocytes (Ery.) <0.8xLLN	0 0%	0 0%	0 0%	1 16.7%
Ery. Mean Corpuscular Volume <0.9xLLN	0 0%	1 16.7%	0 0%	0 0%
Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN)	0 0%	0 0%	0 0%	1 16.7%
Ery. Mean Corpuscular Hemoglobin <0.9xLLN	0 0%	1 16.7%	0 0%	0 0%
Ery. Mean Corpuscular Hemoglobin >1.1xULN	0 0%	0 0%	0 0%	2 33.3%
Platelets <0.5xLLN	0 0%	0 0%	0 0%	1 16.7%
Leukocytes <0.6xLLN	0 0%	0 0%	0 0%	1 16.7%
Lymphocytes <0.8xLLN	0 0%	0 0%	0 0%	1 16.7%
Neutrophils <0.8xLLN	0 0%	0 0%	1 16.7%	0 0%
Monocytes >1.2xULN	0 0%	0 0%	1 16.7%	0 0%
Activated Partial Thromboplastin Time >1.1xULN	1 16.7%	1 16.7%	2 33.3%	2 33.3%
Prothrombin Time >1.1xULN	0 0%	0 0%	0 0%	3 50%
Prothrombin International. Normalized Ratio >1.1xULN	0 0%	0 0%	0 0%	3 50%
Bilirubin >1.5xULN	0 0%	0 0%	1 16.7%	4 66.7%
Direct Bilirubin >1.5xULN	0 0%	0 0%	1 16.7%	4 66.7%
Indirect Bilirubin >1.5xULN	0 0%	0 0%	0 0%	1 16.7%
Aspartate Aminotransferase >3.0xULN	0 0%	0 0%	1 16.7%	0 0%
Alanine Aminotransferase >3.0xULN	0 0%	0 0%	1 16.7%	0 0%
Gamma Glutamyl Transferase >3.0xULN	0 0%	0 0%	0 0%	1 16.7%
Albumin <0.8xLLN	0 0%	0 0%	1 16.7%	1 16.7%
Glucose >1.5xULN	0 0%	2 33.3%	1 16.7%	0 0%
Urine Glucose ≥1	0 0%	0 0%	0 0%	1 16.7%
Urine Ketones ≥1	0 0%	0 0%	1 16.7%	0 0%
Urine Protein ≥1	0 0%	0 0%	0 0%	1 16.7%
Urine Hemoglobin ≥1	2 33.3%	1 16.7%	2 33.3%	0 0%
Urine Urobilinogen ≥1	0 0%	0 0%	1 16.7%	2 33.3%
Urine Bilirubin ≥1	0 0%	0 0%	1 16.7%	0 0%
Urine Nitrite ≥1	0 0%	0 0%	1 16.7%	0 0%
Urine Leukocytes ≥20	0 0%	1 16.7%	1 16.7%	0 0%
Urine Bacteria >20	0 0%	1 16.7%	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) 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 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.
Measure Participants	6	6	6	6
Systolic Blood Pressure (mmHg) Value <90 mmHg	0 0%	0 0%	0 0%	0 0%
Systolic Blood Pressure (mmHg) Change >=30 mmHg increase	0 0%	0 0%	0 0%	0 0%
Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease	0 0%	0 0%	0 0%	0 0%
Diastolic Blood Pressure (mmHg) Value <50 mmHg	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%
Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease	0 0%	0 0%	1 16.7%	0 0%
Pulse Rate (beats per minute [bpm]) Value <40 bpm	0 0%	0 0%	0 0%	0 0%
Pulse Rate (bpm) Value >120 bpm	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 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 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.
Measure Participants	6	6	6	6
QTcF (millisecond [msec]) 450< Value <=480	0 0%	0 0%	1 16.7%	1 16.7%
QTcF (msec) 480< Value <=500	0 0%	0 0%	0 0%	0 0%
QTcF (msec) Value >500	0 0%	0 0%	0 0%	0 0%
QTcF (msec) 30<= Change <=60	0 0%	0 0%	0 0%	0 0%
QTcF (msec) Change >60	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Up to Day 32 (31 days after investigational product administration)
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 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.