A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07248839
Phase
PHASE1
Status
Recruiting

Conditions

  • Healthy Volunteers
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • BMS-986435 — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment

Key Dates

Start date
Dec 15, 2025
Status verified
Jun 2026
Primary completion
Aug 5, 2026
Completion
Aug 5, 2026

Study Design

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

Arms

  • Experimental: Arm A
    Mild Hepatic Impairment
  • Experimental: Arm B
    Moderate Hepatic Impairment
  • Experimental: Arm C
    Matched participants with normal hepatic function

Primary Outcome Measure

Maximum observed concentration (Cmax) [ Time Frame: Up to Day 45 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
  • First line of the email MUST contain the NCT# and Site #.

Locations (3)

FacilityCityStateZIPSite coordinators
Arizona Clinical TrialsChandlerArizona85225
Anita Kohli, Site 0003
434-825-0921
Panax Clinical ResearchMiami LakesFlorida33014
Robert Perry, Site 0002
305-698-4500
Texas Liver InstituteSan AntonioTexas78215
Eric Lawitz, Site 0001
210-253-3426

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