Actively Recruiting
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Led by Pfizer · Updated on 2026-05-12
28
Participants Needed
4
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function. The study will include participants who: * Are aged 18 to 80 years. * Either have normal kidney function or long-term reduced kidney function (moderate or severe). * Have a BMI (body mass index) of 17.5 to 40 kilogram per meter squared, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds. All participants will receive a single dose of PF-07328948 as a tablet taken by mouth. Participants will stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks. Total participation lasts up to 64 days, including screening, inpatient stay, and a follow-up call. The study is not randomized or blinded, meaning all participants and study staff know which treatment is being given. Group assignment is based on kidney function tests done during screening. The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body.
CONDITIONS
Official Title
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of nonchildbearing potential, aged 18 to 80 years at screening
- Body mass index between 17.5 and 40.0 kg/m2 and total body weight of at least 45 kilograms (99 pounds)
- Stable renal function with less than or equal to 25% difference between two eGFR measurements
- For normal kidney function group: no clinically relevant abnormalities by medical history, physical exam, ECG, and lab tests
- Normal renal function group: mean eGFR of at least 90 mL/min at screening
- For chronic renal impairment groups: good general health consistent with chronic kidney impairment
- Chronic renal impairment defined as mean eGFR between 15 and less than 60 mL/min, not requiring hemodialysis
You will not qualify if you...
- Any condition that may affect drug absorption
- Positive HIV antibody test at screening
- History of renal, liver, or heart transplantation
- Urinary incontinence without catheterization
- History or evidence of prothrombotic state or known genetic predisposition
- Use of investigational product within 30 days or 5 half-lives, whichever is longer
- Positive urine drug test or breath alcohol test at screening or admission
- For normal kidney function group: clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- For normal kidney function group: ECG showing QTcF >450 ms or QRS >120 ms
- For normal kidney function group: seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
- For chronic renal impairment groups: acute renal disease, need for or anticipated dialysis, or listed for solid organ transplantation
- For chronic renal impairment groups: persistent severe uncontrolled hypertension at screening or admission
- For chronic renal impairment groups: ECG showing QTcF >470 ms or QRS >120 ms
- For chronic renal impairment groups: unstable medical conditions or comorbidities interfering with participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 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
4
Nucleus Network
Saint Paul, Minnesota, United States, 55114
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
3
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