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RECRUITING
NCT07315360
PHASE1

A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-01-28

Completion Date

2027-03-13

Last Updated

2026-03-18

Healthy Volunteers

Yes

Interventions

DRUG

PF-07328948

PF-07328948 , 1 tablet orally, once on Day 1

Locations (4)

Orange County Research Center

Lake Forest, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Genesis Clinical Research, LLC

Tampa, Florida, United States

Nucleus Network

Saint Paul, Minnesota, United States