A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

Pfizer2 sites in 1 country24 target enrollmentAugust 1, 2022

ConditionsHepatic Impairment Healthy Volunteers

InterventionsPF-07081532

Overview

Phase: Phase 1
Intervention: PF-07081532
Conditions: Hepatic Impairment
Sponsor: Pfizer
Enrollment: 24
Locations: 2
Primary Endpoint: Maximum Plasma Concentration (Cmax) of PF-07081532
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people.

We are seeking participants who:

Are between 18 and 70 years of age;
Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs.).

Participants will take the study medicine as a tablet once at the study clinic, and then will stay onsite for about 7 days. During this time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain level of liver functional impairment could affect the study medicine being processed in the body.

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

April 5, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between the ages of 18 and 70 years, inclusive at the screening visit.
•Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
•BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lb).
•Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
•Group 1 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
•Groups 2, 3 \& 4 only: stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh classification with no clinically significant change in disease status within 28 days before screening.
•Groups 2, 3 \& 4 only: stable concomitant medications for the management of individual participant's medical history.

Exclusion Criteria

•Any condition possibly affecting drug absorption
•At screening, a positive result for HIV antibodies.
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or participants with suspected MTC per study doctor's judgement.
•History of acute pancreatitis within 6 months before the screening visit or any history of chronic pancreatitis.
•Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
•Use of specific prohibited prior/concomitant therapies
•Use of an investigational product within 30 days (or local requirement) or 5 half-lives (whichever longer).
•eGFR\<60 mL/min/1.73m2 at screening.
•A positive urine drug test at screening or admission to study clinic.
•At screening or admission to study clinic, a positive breath alcohol test.

Arms & Interventions

Group 1: PF-07081532 Participants without hepatic impairment

Participants without hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.

Intervention: PF-07081532

Group 2: PF-07081532 Participants with mild hepatic impairment

Participants with mild hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet

Intervention: PF-07081532

Group 3: PF-07081532 Participants with moderate hepatic impairment

Participants with moderate hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.

Intervention: PF-07081532

Group 4: PF-07081532 Participants with severe hepatic impairment

Participants with severe hepatic impairment will receive a single20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.

Intervention: PF-07081532