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)
24
Enrollment
2
Locations
4
Arms
6.1
Actual Duration (Months)
12
Patients Per Site
2
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1University of Miami Division of Clinical PharmacologyMiamiFloridaUnited States33136
2Orlando Clinical Research CenterOrlandoFloridaUnited States32809

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailOf 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 TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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
STARTED6666
COMPLETED6666
NOT COMPLETED0000

Baseline Characteristics

Arm/Group TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)Total
Arm/Group DescriptionHepatic 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 Participants666624
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
TitleMaximum Observed Plasma Concentration (Cmax)
DescriptionCmax of PF-06865571 was observed directly from data.
Time FrameFor 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 TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value156.99
Confidence Interval (2-Sided) 90%
83.14 to 296.44
Parameter Dispersion Type:
Value:
Estimation Comments90% 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value125.58
Confidence Interval (2-Sided) 90%
66.51 to 237.13
Parameter Dispersion Type:
Value:
Estimation Comments90% 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value123.75
Confidence Interval (2-Sided) 90%
65.54 to 233.68
Parameter Dispersion Type:
Value:
Estimation Comments90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference
2. Primary Outcome
TitleArea Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
DescriptionAUClast of PF-06865571 was determined by linear/log trapezoidal method.
Time FrameFor 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 TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value156.25
Confidence Interval (2-Sided) 90%
81.07 to 301.16
Parameter Dispersion Type:
Value:
Estimation Comments90% 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value165.66
Confidence Interval (2-Sided) 90%
85.95 to 319.29
Parameter Dispersion Type:
Value:
Estimation Comments90% 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value152.18
Confidence Interval (2-Sided) 90%
78.96 to 293.32
Parameter Dispersion Type:
Value:
Estimation Comments90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference
3. Primary Outcome
TitleArea Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
DescriptionAUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
Time FrameFor 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 TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value156.00
Confidence Interval (2-Sided) 90%
80.95 to 300.60
Parameter Dispersion Type:
Value:
Estimation Comments90% 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value165.38
Confidence Interval (2-Sided) 90%
85.82 to 318.67
Parameter Dispersion Type:
Value:
Estimation Comments90% 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 Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio (%)
Estimated Value152.20
Confidence Interval (2-Sided) 90%
78.99 to 293.29
Parameter Dispersion Type:
Value:
Estimation Comments90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference
4. Secondary Outcome
TitleNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)
DescriptionAn 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 FrameUp to Day 32 (31 days after investigational product administration)

Outcome Measure Data

Analysis Population Description
All participants who received PF-06865571.
Arm/Group TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
5. Secondary Outcome
TitleNumber of Participants With Clinical Laboratory Abnormalities
DescriptionThe following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.
Time FrameUp to Day 4 (3 days after investigational product administration)

Outcome Measure Data

Analysis Population Description
All participants who received PF-06865571.
Arm/Group TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
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
TitleNumber of Participants With Categorical Vital Signs Data
DescriptionVital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.
Time FrameUp to Day 4 (3 days after investigational product administration)

Outcome Measure Data

Analysis Population Description
All participants who received PF-06865571.
Arm/Group TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
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
TitleNumber of Participants With Categorical Electrocardiogram (ECG)
DescriptionQT 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 FrameUp to Day 4 (3 days after investigational product administration)

Outcome Measure Data

Analysis Population Description
All participants who received PF-06865571.
Arm/Group TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 Participants6666
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 FrameUp to Day 32 (31 days after investigational product administration)
Adverse Event Reporting Description
Arm/Group TitleCohort 1 (Without Hepatic Impairment)Cohort 2 (Mild Hepatic Impairment)Cohort 3 (Moderate Hepatic Impairment)Cohort 4 (Severe Hepatic Impairment)
Arm/Group DescriptionHepatic 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 (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (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 (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (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 (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (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.

Results Point of Contact

Name/TitlePfizer ClinicalTrials.gov Call Center
OrganizationPfizer Inc.
Phone1-800-718-1021
EmailClinicalTrials.gov_Inquiries@pfizer.com
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