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

Part of paid clinical trials in Lake Forest, California.

Sponsor
Pfizer
Study ID
NCT07315360
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • PF-07328948 — DRUG
    PF-07328948 , 1 tablet orally, once on Day 1

Study Details

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.

Key Dates

Start date
Jan 28, 2026
Status verified
May 2026
Primary completion
Mar 13, 2027
Completion
Mar 13, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: PF-07328948 participants without renal impairment
    Participants without renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
  • Experimental: Group 2: PF-07328948 participants with severe renal impairment
    Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
  • Experimental: Group 3: PF-07328948 participants with moderate renal impairment
    Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.

Primary Outcome Measure

Fraction of Unbound Drug in Plasma (Fu) of PF-07328948 [ Time Frame: 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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Orange County Research CenterLake ForestCalifornia92630-
Orlando Clinical Research CenterOrlandoFlorida32809-
Genesis Clinical Research, LLCTampaFlorida33603-
Nucleus NetworkSaint PaulMinnesota55114-

Find similar trials in Lake Forest, CA

By research site
Orange County Research Center· Lake Forest, CAOrlando Clinical Research Center· Orlando, FLGenesis Clinical Research, LLC· Tampa, FLNucleus Network· Saint Paul, MN

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