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

NCT04604496 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C3421014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  Maximum observed plasma PF-06882961 concentration.

  Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)

  Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.

  Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

• Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

  Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.

  Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

• Fraction of Unbound Drug in Plasma (fu)

  fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).

  Predose (0 hours), and 4 hours post dose on Day 1.

Secondary Outcomes (4)

• Number of Participants Reporting Treatment-emergent Adverse Events (AEs)

  Baseline to Day 30

• Number of Participants With Clinical Laboratory Abnormalities

  Baseline to Day 3

• Number of Participants With Categorical Vital Signs Data

  Baseline to Day 3

• Number of Participants With Categorical Electrocardiogram (ECG) Data

  Baseline to Day 3

Study Arms (4)

PF-06882961 participants without Hepatic Impairment

EXPERIMENTAL

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

Drug: PF-06882961 20MG

PF-06882961 participants with mild Hepatic Impairment

EXPERIMENTAL

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

Drug: PF-06882961 20MG

PF-06882961 participants with moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: PF-06882961 20MG

PF-06882961 participants with severe Hepatic Impairment

EXPERIMENTAL

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

Drug: PF-06882961 20MG

Interventions

PF-06882961 20MG DRUG

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

PF-06882961 participants with mild Hepatic Impairment; PF-06882961 participants with moderate Hepatic Impairment; PF-06882961 participants with severe Hepatic Impairment; PF-06882961 participants without Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Links

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

MeSH Terms

Interventions

danuglipron

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: December 30, 2020
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)