A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Condition(s) studied
Investigational drug(s) / intervention(s)
PF-07328948: PF-07328948 , 1 tablet orally, once on Day 1
Study summary
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.
Eligibility
Primary outcome measure(s)
- Fraction of Unbound Drug in Plasma (Fu) of PF-07328948 — At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 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-07328948 — At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 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-07328948 — At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Orange County Research Center | Lake Forest | California | Recruiting |
| Orlando Clinical Research Center | Orlando | Florida | Recruiting |
| Genesis Clinical Research, LLC | Tampa | Florida | Recruiting |
| Nucleus Network | Saint Paul | Minnesota | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07315360 on ClinicalTrials.gov ↗ ← All trials in the USA