A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Pfizer
Study ID
NCT07519135
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Accepted

Interventions

  • PF-08653944 — DRUG
    Solution for injection

Study Details

This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose. The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body. People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks. This study is not expected to provide direct medical benefit to participants. The information collected will help researchers develop future treatments and understand how this medicine may be used safely in people with liver disease.

Key Dates

Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
Jul 9, 2027
Completion
Jul 9, 2027

Study Design

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

Arms

  • Experimental: Group 1
    Participants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection.
  • Experimental: Group 2
    Participants with mild HI will receive a single dose of PF-08653944, administered as SC injection.
  • Experimental: Group 3
    Participants with moderate HI will receive a single dose of PF-08653944, administered as SC injection.
  • Experimental: Group 4
    Participants with severe HI will receive a single dose of PF 08653944, administered as SC injection.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944 [ Time Frame: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Floridian Clinical ResearchMiami LakesFlorida33016-
Orlando Clinical Research CenterOrlandoFlorida32809-
Genesis Clinical ResearchTampaFlorida33603-

Find similar trials in Miami Lakes, FL

By research site
Floridian Clinical Research· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLGenesis Clinical Research· Tampa, FL

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