A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function

Part of paid clinical trials in Lake Forest, California.

Sponsor
Pfizer
Study ID
NCT07269301
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 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 understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people. Study is seeking participants who: * Are between 18 and 75 years of age. * Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds. Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days. During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.

Key Dates

Start date
Dec 22, 2025
Status verified
May 2026
Primary completion
Feb 23, 2027
Completion
Feb 23, 2027

Study Design

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

Arms

  • Experimental: Group 1: PF-07328948 participants with severe hepatic impairment
    Participants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
  • Experimental: Group 2: PF-07328948 participants with moderate hepatic impairment
    Participants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
  • Experimental: Group 3: PF-07328948 participants with mild hepatic impairment
    Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
  • Experimental: Group 4: PF-07328948 participants without hepatic impairment
    Participants without hepatic 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, 120, and 168 hours post dose on Day 1 ]

Central Contacts

Locations (3)

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

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, FL

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