A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function

NCT07269301 | Recruiting Phase 1 FDA Drug

• 1 other identifier: C4921011
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people. Study is seeking participants who:

• Are between 18 and 75 years of age.
• Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds. Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days. During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.

Conditions

Hepatic Impairment; Healthy

Outcome Measures

Primary Outcomes (3)

• Fraction of Unbound Drug in Plasma (Fu) of PF-07328948

  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, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1

• Unbound AUCinf (AUCinf,u) of PF-07328948

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

  At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1

• Unbound Cmax (Cmax,u) of PF-07328948

  Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.

  At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1

Secondary Outcomes (1)

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

  Day 1 to Day 36

Study Arms (4)

Group 1: PF-07328948 participants with severe hepatic impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Group 2: PF-07328948 participants with moderate hepatic impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Group 3: PF-07328948 participants with mild hepatic impairment

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Group 4: PF-07328948 participants without hepatic impairment

EXPERIMENTAL

Participants without hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Drug: PF-07328948

Interventions

PF-07328948 DRUG

PF-07328948, 1 tablet orally, once on Day 1

Group 1: PF-07328948 participants with severe hepatic impairment; Group 2: PF-07328948 participants with moderate hepatic impairment; Group 3: PF-07328948 participants with mild hepatic impairment; Group 4: PF-07328948 participants without hepatic impairment

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of nonchildbearing potential, between the ages of 18 (inclusive) and 75 years, 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 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lb).
• Group 4 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 4 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
• Groups 1, 2 \& 3 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 1, 2 \& 3 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.
• Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
• 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 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.
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
• Group 4 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C.
• Group 4 only: screening ECG demonstrating QTcF interval \>450 ms or a QRS interval \>120 ms.
• Group 4 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
• Group 1, 2 \& 3 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as \<1 year in Groups 2 \& 3 and \<6 months for Group 1 only).
• Group 1, 2 \& 3 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

RECRUITING

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

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: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)