A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function (NCT07315360)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Orange County Research Center โ Lake Forest, California
Age range: 18 Years to 80 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- Orange County Research Center โ Lake Forest, California
- Orlando Clinical Research Center โ Orlando, Florida
- Genesis Clinical Research, LLC โ Tampa, Florida
- Nucleus Network โ Saint Paul, Minnesota
๐ Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Renal Impairment
Explore by condition: All Renal Impairment clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.