A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
NCT06433505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-03-26
Summary
The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
BMS-986365
Specified dose on specified days
- DRUG
-
[14C] BMS-986365
Specified dose on specified days.
- DRUG
-
[14C] BMS-986409 + BMS-986410
Specified dose on specified days
- DRUG
-
[14C] BMS-986410 + BMS-986409
Specified dose on specified days
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-30
- Primary Completion
- 2025-02-14
- Completion
- 2025-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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