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A Study on How Your Body Processes PF-07328948 With or Without Liver Problems

This study aims to understand how your body processes the medicine PF-07328948, especially if you have reduced liver function. People with liver problems might process medicines differently than healthy individuals. Researchers will give you one tablet of PF-07328948 by mouth. They will then measure the levels of PF-07328948 in your blood over several days to see how much of the medicine is active in your system. This study is looking for 26 participants, both healthy individuals and those with liver impairment, between 18 and 75 years old, with a specific body mass index (BMI). The study status is currently unclear.

Study design
This is an interventional study involving 26 participants, including both healthy individuals and those with liver impairment. It is not specified if it is randomized or blinded.
What's involved
You will take one tablet of PF-07328948 at the study clinic and stay onsite for about 6 days. During this time, the study team will monitor your experience and take blood samples to measure the medicine's levels.
Compensation
Not stated in the trial record.
Follow-up
Blood samples will be taken and analyzed for up to 168 hours (7 days) after you take the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07269301

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

Recruiting
PHASE1Ages 18–74InterventionalBasic science
Pfizer
~26 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:PF-07328948

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
Measured over 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
+2 more outcomes measured

Conditions

Hepatic Impairment
Healthy

Explore related trials

HealthyLiver Failure

Where it's being run

3 sites across 2 states
Florida2
California1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

    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).

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

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

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

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