Actively Recruiting
Phase 1 Study to Understand How PF-07328948 is Processed in Adults With and Without Liver Impairment Single Dose Oral Tablet in Adults 18 to 75 Years
Led by Pfizer · Updated on 2026-07-23
26
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how decreased liver function affects the way the body processes the medicine PF-07328948. The study involves adults aged 18 to 75 years with varying degrees of liver function, including healthy individuals and those with mild, moderate, or severe liver impairment. The goal is to understand if liver function changes the processing of this medicine in the body. Participants will receive a single oral dose of PF-07328948 tablet at the study clinic. Four groups are studied in parallel one with no liver impairment, and three with mild, moderate, or severe hepatic impairment. After taking the dose, participants will stay at the clinic for about six days for monitoring and testing. During the clinic stay, the study team will observe participants for treatment experience and collect blood samples at multiple time points to measure levels of PF-07328948. This helps assess how the liver function affects drug levels. Safety will be evaluated through adverse event monitoring up to 36 days. The total study duration includes dosing and follow-up assessments to understand the medicines behavior and tolerability.
CONDITIONS
Brief Title
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of nonchildbearing potential, between 18 and 75 years old at screening
- Willing and able to follow all study visits, treatment plan, laboratory tests, lifestyle rules, and procedures
- Body mass index between 17.5 and 40 kg/m2 and total body weight of at least 45 kilograms (99 pounds)
- Group 4 only: no liver impairment or abnormal liver tests, and no significant health issues found during screening
- Groups 1, 2 & 3 only: stable mild, moderate, or severe liver impairment meeting Child-Pugh classification with no major disease change in 28 days before screening
- Groups 1, 2 & 3 only: stable medications for their medical condition
You will not qualify if you...
- Any condition that could affect how the body absorbs drugs
- Positive HIV antibody test at screening
- History of blood clotting problems or genetic clotting risks
- Other medical or psychiatric conditions or lab abnormalities increasing study risk
- Use of prohibited therapies or investigational products within 30 days or 5 half-lives
- Kidney function below eGFR 60 mL/min/1.73m2 at screening
- Positive urine drug or breath alcohol test at screening or admission
- History of alcohol abuse, binge drinking, or illicit drug use within 6 months
- Group 4 only: chronic liver disease or hepatitis history
- Group 4 only: abnormal ECG or high blood pressure at screening
- Groups 1, 2 & 3 only: liver cancer, hepatorenal syndrome, or limited life expectancy
- Groups 1, 2 & 3 only: recent gastrointestinal bleeding or active severe liver encephalopathy
- Groups 1, 2 & 3 only: severe ascites or pleural effusion unless medically stable
- Groups 1, 2 & 3 only: prior kidney, liver, or heart transplant
- Groups 1, 2 & 3 only: abnormal ECG or uncontrolled severe hypertension at screening
- Groups 1, 2 & 3 only: very high liver enzyme levels at screening
Research Team
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