Trials / Recruiting
RecruitingNCT07315360
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-07328948 | PF-07328948 , 1 tablet orally, once on Day 1 |
Timeline
- Start date
- 2026-01-28
- Primary completion
- 2027-03-13
- Completion
- 2027-03-13
- First posted
- 2026-01-02
- Last updated
- 2026-03-18
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07315360. Inclusion in this directory is not an endorsement.