A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

NCT ID: NCT05478603

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-04-05

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.

Conditions

Hepatic Impairment; Healthy Volunteers

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1

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

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1

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.

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1

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.

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1

Interventions

PF-07081532

PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1

Intervention Type: DRUG

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.
• For females, pregnancy, as indicated by a positive serum pregnancy test at screening and/or positive urine pregnancy test in women capable of having children at admission to study clinic
• Group 1 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C.
• Group 1 only: history of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
• Group 1 only: screening ECG demonstrating QTcF interval >450 ms or a QRS interval >120 ms.
• Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
• Group 1 only: use of chronic prescription medications within 7 days or 5 half-lives (whichever longer) before Day 1, or for prohibited medications, use within the required washout/restriction period.
• Group 2, 3 & 4 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year in Groups 2 & 3 and <6 months for Group 4 only).
• Group 2, 3 & 4 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, CT scan, or MRI.
• Group 2, 3 & 4 only: history of surgery that would be expected to alter absorption, distribution, metabolism, or excretion properties of PF-07081532.
• Group 2, 3 & 4 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.
• Group 2, 3 & 4 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy
• Groups 2, 3 & 4 only: severe ascites and/or pleural effusion, except for those categorized in Group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment.
• Groups 2, 3 & 4 only: previously received a kidney, liver, or heart transplant.
• Groups 2, 3, & 4 only: screening ECG demonstrating a QTcF interval >470 ms or a QRS interval >120 ms.
• Groups 2, 3 & 4 only: at screening, admission to study clinic or pre-dose on Day 1, persistent severe, uncontrolled hypertension.
• Groups 2, 3 & 4 only: ALT or AST >5x upper limit of normal on clinical laboratory tests at screening.

• 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

Orlando Clinical Research Center

Orlando, Florida, United States

Genesis Clinical Research, LLC

Tampa, Florida, United States

Countries

United States

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=C3991009

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

Other Identifiers

C3991009

Identifier Type: -

Identifier Source: org_study_id