Recruiting

Phase 1

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

Sponsor:

Pfizer

Code:

NCT07269301

Conditions

Hepatic Impairment

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

PF-07328948

Study Details

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

Study ID

NCT07269301

Start date

Dec 22, 2025

Status verified date

Jul, 2026

Completion date

Feb 23, 2027

Anticipated

Primary completion date

Feb 23, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Group 1, 2 \& 3 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.
Group 1, 2 \& 3 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy
Groups 1, 2 \& 3 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 1, 2 \& 3 only: previously received a kidney, liver, or heart transplant.
Groups 1, 2, \& 3 only: screening ECG demonstrating a QTcF interval >470 ms or a QRS interval >120 ms.
Groups 1, 2 \& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.
Groups 1, 2 \& 3 only: ALT or AST >5x upper limit of normal on clinical laboratory tests at screening.

Study Design

Enrollment

26 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group 4: PF-07328948 participants without hepatic impairment

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

experimental: Group 2: PF-07328948 participants with moderate hepatic impairment

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

experimental: Group 3: PF-07328948 participants with mild hepatic impairment

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

experimental: Group 1: PF-07328948 participants with severe hepatic impairment

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

Interventions

PF-07328948

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

Primary outcome measure

Fraction of Unbound Drug in Plasma (Fu) of PF-07328948 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Genesis Clinical Research, LLC

Recruiting

Tampa, Florida, United States, 33603

More Information

Sponsor

Pfizer

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-23.