STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

NCT ID: NCT04604496

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2022-01-10

Brief Summary

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961

Conditions

Hepatic Impairment; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

PF-06882961 participants without Hepatic Impairment

This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1

Group Type: EXPERIMENTAL

PF-06882961 20MG

Intervention Type: DRUG

PF-06882961 in 20 mg oral tablet will be administered on Day 1

PF-06882961 participants with mild Hepatic Impairment

This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

Group Type: EXPERIMENTAL

PF-06882961 20MG

Intervention Type: DRUG

PF-06882961 in 20 mg oral tablet will be administered on Day 1

PF-06882961 participants with moderate Hepatic Impairment

This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

Group Type: EXPERIMENTAL

PF-06882961 20MG

Intervention Type: DRUG

PF-06882961 in 20 mg oral tablet will be administered on Day 1

PF-06882961 participants with severe Hepatic Impairment

This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

Group Type: EXPERIMENTAL

PF-06882961 20MG

Intervention Type: DRUG

PF-06882961 in 20 mg oral tablet will be administered on Day 1

Interventions

PF-06882961 20MG

PF-06882961 in 20 mg oral tablet will be administered on Day 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female participants between the ages of 18 (or the minimum country-specific age of consent if >18) and 70 years, inclusive, at the screening visit:
• 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 38.0 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.

Exclusion Criteria

• Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening;
• 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;
• A positive COVID-19 test at screening;
• A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study;
• Use of prior/concomitant therapies
• 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-06882961;
• Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;

• A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;
• At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;
• 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; 13. History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections;
• Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

• 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

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=C3421014

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

Other Identifiers

C3421014

Identifier Type: -

Identifier Source: org_study_id