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 — DRUGSpecified 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 AMild Hepatic Impairment
- Experimental: Arm BModerate Hepatic Impairment
- Experimental: Arm CMatched 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.com855-907-3286
- First line of the email MUST contain the NCT# and Site #.
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Clinical Trials | Chandler | Arizona | 85225 | Anita Kohli, Site 0003 434-825-0921 |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | Robert Perry, Site 0002 305-698-4500 |
| Texas Liver Institute | San Antonio | Texas | 78215 | Eric Lawitz, Site 0001 210-253-3426 |
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