A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function

Part of paid clinical trials in Miami, Florida.

Sponsor
Pfizer
Study ID
NCT07231991
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • vepdegestrant — DRUG
    Vepdegestrant administered as a single oral 200 mg dose

Study Details

The purpose of the study is to look at how the body processes a study medicine called vepdegestrant in participants with loss of liver function relative to people with normal liver function. This study is seeking participants who are: * females who cannot have children or males * between 18 and 70 years of age * weigh more than 50 Kilograms (110 pounds) * either healthy with normal liver function or have loss of liver function All participants in this study will take one dose of vepdegestrant by mouth. This study looks at how the medicine is changed and removed from the body after being taken by the participants. The amount of vepdegestrant in participants with loss of liver function will be compared to the amount of vepdegestrant in participants with normal liver function. All participants will stay at the study clinic for about 11 days and 10 nights.

Key Dates

Start date
Nov 18, 2025
Status verified
Mar 2026
Primary completion
Dec 4, 2026
Completion
Dec 23, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1
    participants with normal hepatic function
  • Experimental: Group 2
    participants with moderate hepatic impairment
  • Experimental: Group 3
    participants with severe hepatic impairment

Primary Outcome Measure

Maximum observed concentration (Cmax) for vepdegestrant [ Time Frame: Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33172-
Floridian Clinical Research, LLCMiami LakesFlorida33016-
Orlando Clinical Research CenterOrlandoFlorida32809-
Genesis Clinical Research, LLCTampaFlorida33603-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami· Miami, FLFloridian Clinical Research, LLC· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLGenesis Clinical Research, LLC· Tampa, FL

Related Studies