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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

Primary Purpose

Hepatic Impairment, Healthy Volunteers

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-06865571 100 mg

About this trial

This is an interventional basic science trial for Hepatic Impairment focused on measuring Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Miami Division of Clinical Pharmacology
Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

PF-06865571 Moderate Hepatic Impairment

PF-06865571 Severe Hepatic Impairment

PF-06865571 Mild Hepatic Impairment

PF-06865571 Healthy Participants

Arm Description

This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Cmax of PF-06865571 was observed directly from data.

Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)

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

Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)

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

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Number of Participants With Clinical Laboratory Abnormalities

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

Number of Participants With Categorical Vital Signs Data

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

Number of Participants With Categorical Electrocardiogram (ECG)

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.

Full Information

NCT ID

NCT04091061

First Posted

September 13, 2019

Last Updated

March 18, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04091061

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

October 3, 2019 (Actual)

Primary Completion Date

April 7, 2020 (Actual)

Study Completion Date

April 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment, Healthy Volunteers

Keywords

Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06865571 Moderate Hepatic Impairment

Arm Type

Experimental

Arm Description

This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

Arm Title

PF-06865571 Severe Hepatic Impairment

Arm Type

Experimental

Arm Description

This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

Arm Title

PF-06865571 Mild Hepatic Impairment

Arm Type

Experimental

Arm Description

This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

Arm Title

PF-06865571 Healthy Participants

Arm Type

Experimental

Arm Description

This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1

Intervention Type

Drug

Intervention Name(s)

PF-06865571 100 mg

Intervention Description

PF-06865571 in 100 mg oral tablet will be administered on Day 1

Primary Outcome Measure Information:

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.

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.

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.

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Up to Day 32 (31 days after investigational product administration)

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)

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)

Title

Number of Participants With Categorical Electrocardiogram (ECG)

Description

Time Frame

Up to Day 4 (3 days after investigational product administration)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Miami Division of Clinical Pharmacology

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=C2541009

Description

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

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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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