Actively Recruiting
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of PF-07328948 in Adults With and Without Liver Impairment
Led by Pfizer · Updated on 2026-05-26
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 study medicine PF-07328948. This study aims to understand differences in medicine processing among people with various levels of liver impairment compared to those without liver problems. It is a Phase 1, open-label trial focusing on pharmacokinetics, safety, and tolerability of PF-07328948 in adults aged 18 to 75 years. Participants will receive a single oral dose of one PF-07328948 tablet at the study clinic. Four groups are included: those with severe, moderate, and mild hepatic impairment, and those without liver impairment. Each participant will stay onsite for about 6 days following dosing, during which their treatment experience and blood levels of PF-07328948 will be closely monitored. During the study, staff will collect blood samples at multiple time points up to 168 hours after dosing to measure unbound drug levels in plasma. Safety will be assessed by recording any treatment-related side effects up to 36 days. Participants must comply with scheduled visits, tests, and procedures during their stay. The total body weight and BMI of participants will also be evaluated to ensure eligibility.
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, aged 18 to 75 years at screening
- Willing and able to follow all study visits, treatment plans, lab tests, and procedures
- Body mass index between 17.5 and 40.0 kg/m2, with weight at least 45 kg (99 lb)
- For participants without liver impairment: no significant medical abnormalities and normal liver function tests
- For participants with liver impairment: stable hepatic impairment classified as mild, moderate, or severe using Child-Pugh classification
- Stable medications for managing existing medical conditions
You will not qualify if you...
- Conditions that might affect drug absorption
- Positive HIV antibody test at screening
- History or evidence of blood clotting disorders
- Other medical or psychiatric conditions increasing study risk
- Use of prohibited therapies or investigational products within 30 days
- Reduced kidney function (eGFR less than 60 mL/min/1.73m2)
- Positive drug or alcohol tests at screening or admission
- Recent alcohol abuse, binge drinking, or illicit drug use within 6 months
- For participants without liver impairment: any chronic liver disease or abnormal ECG or blood pressure
- For participants with liver impairment: liver cancer, hepatorenal syndrome, or limited life expectancy
- Recent gastrointestinal bleeding or severe liver encephalopathy
- Severe fluid accumulation or pleural effusion unless medically stable
- History of kidney, liver, or heart transplant
- Abnormal ECG findings or uncontrolled severe hypertension
- Elevated liver enzymes (ALT or AST more than 5 times normal) at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single oral dose of the study medicine PF-07328948.
1 dosing visit and multiple blood sample collections over 7 days
Duration - Up to 36 days
Participants are monitored for safety and any treatment emergent adverse events after dosing.
Periodic visits or contacts during the follow-up period
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
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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