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

NCT ID: NCT04091061

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-03
• Study Completion Date: 2020-04-07

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.

Conditions

Hepatic Impairment; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PF-06865571 100 mg

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

PF-06865571 100 mg

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

PF-06865571 100 mg

Intervention Type: DRUG

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

PF-06865571 Healthy Participants

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

Group Type: EXPERIMENTAL

PF-06865571 100 mg

Intervention Type: DRUG

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

Interventions

PF-06865571 100 mg

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of Miami Division of Clinical Pharmacology

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

References

Vourvahis M, Bergman AJ, Ogden AG, Hughes J, Gosset JR, Kalgutkar AS, Amin NB. Effect of Varying Degrees of Hepatic Impairment on the Pharmacokinetics of Ervogastat, a Diacylglycerol Acyltransferase 2 (DGAT2) Inhibitor, and Clesacostat, an Acetyl-CoA Carboxylase (ACC) Inhibitor. J Clin Pharmacol. 2025 Sep 25. doi: 10.1002/jcph.70106. Online ahead of print.

Reference Type: DERIVED

PMID: 40996355 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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

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

Other Identifiers

C2541009

Identifier Type: -

Identifier Source: org_study_id