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

NCT05478603 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C3991009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

Hepatic impairment; Healthy volunteers

Outcome Measures

Primary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of PF-07081532

  Cmax is the maximum plasma concentration.

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

• Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532

  AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time.

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 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) of PF-07081532

  AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

• Fraction of Unbound Drug in Plasma (Fu) of PF-07081532

  Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

• Unbound Cmax (Cmax,u) of PF-07081532

  Cmax,u is the unbound Cmax.

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

• Unbound AUCinf (AUCinf,u) of PF-07081532

  AUCinf,u is the unbound AUCinf.

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

• Unbound AUClast (AUClast,u) of PF-07081532

  AUClast,u is the unbound AUClast.

  At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Day 1 to Day 36

• Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)

  From baseline (BL) to Day 7

• Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria

  From BL to Day 7

• Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

  From BL to Day 7

Study Arms (4)

Group 1: PF-07081532 Participants without hepatic impairment

EXPERIMENTAL

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

Drug: PF-07081532

Group 2: PF-07081532 Participants with mild hepatic impairment

EXPERIMENTAL

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

Drug: PF-07081532

Group 3: PF-07081532 Participants with moderate hepatic impairment

EXPERIMENTAL

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

Drug: PF-07081532

Group 4: PF-07081532 Participants with severe hepatic impairment

EXPERIMENTAL

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

Drug: PF-07081532

Interventions

PF-07081532 DRUG

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

Group 1: PF-07081532 Participants without hepatic impairment; Group 2: PF-07081532 Participants with mild hepatic impairment; Group 3: PF-07081532 Participants with moderate hepatic impairment; Group 4: PF-07081532 Participants with severe 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Related Links

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

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: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: August 1, 2022
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)