Actively Recruiting
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
Led by Pfizer · Updated on 2026-05-12
26
Participants Needed
3
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 scheduled visits, treatment plans, lab tests, lifestyle rules, and study procedures
- Body mass index (BMI) between 17.5 and 40.0 kg/m2 inclusive
- Total body weight of at least 45 kilograms (99 pounds)
- For Group 4 (healthy group): no clinically relevant abnormalities found during medical history, physical exam, blood pressure, pulse, ECG, and lab tests
- For Group 4: no known or suspected liver impairment and meet normal liver function lab criteria
- For Groups 1, 2, and 3 (liver impairment groups): stable liver impairment matching Child-Pugh Class A, B, or C with no significant change in condition within 28 days before screening
- For Groups 1, 2, and 3: stable medications for managing medical history
You will not qualify if you...
- Any condition that may affect drug absorption
- Positive HIV antibody test at screening
- History or signs of blood clotting disorders or genetic predisposition to clotting
- Other medical or psychiatric problems or lab abnormalities that increase risk or make participation unsuitable
- Use of prohibited prior or current therapies
- Use of any investigational drug within 30 days or 5 half-lives (whichever is longer)
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2 at screening
- Positive urine drug test or breath alcohol test at screening or clinic admission
- History of alcohol abuse, binge drinking, or illicit drug use/dependence within 6 months before screening
- For Group 4 only: history or evidence of chronic liver disease including hepatitis B or C
- For Group 4 only: ECG showing QTcF interval over 450 ms or QRS interval over 120 ms
- For Group 4 only: seated systolic blood pressure over 140 mm Hg or diastolic over 90 mm Hg at screening
- For Groups 1, 2, and 3 only: liver cancer, hepatorenal syndrome, or limited life expectancy (less than 1 year for Groups 2 and 3; less than 6 months for Group 1)
- For Groups 1, 2, and 3 only: liver dysfunction due to ongoing acute liver disease documented by medical history or imaging
- For Groups 1, 2, and 3 only: history of gastrointestinal bleeding from esophageal varices or peptic ulcers within 4 weeks before screening
- For Groups 1, 2, and 3 only: signs of severe active hepatic encephalopathy (Grade 3 or 4)
- For Groups 1, 2, and 3 only: severe ascites and/or pleural effusion unless medically stable
- For Groups 1, 2, and 3 only: prior kidney, liver, or heart transplant
- For Groups 1, 2, and 3 only: ECG showing QTcF interval over 470 ms or QRS interval over 120 ms
- For Groups 1, 2, and 3 only: persistent severe uncontrolled high blood pressure at screening or before dose
- For Groups 1, 2, and 3 only: ALT or AST liver enzymes over 5 times the upper normal limit at screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
3
Genesis Clinical Research, LLC
Tampa, Florida, United States, 33603
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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