A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants

Part of paid clinical trials in Miami, Florida.

Sponsor
Celgene
Study ID
NCT07242781
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • BMS-986365 — DRUG
    Specified dose on specified days
  • Itraconazole — DRUG
    Specified dose on specified days
  • Rifampin — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.

Key Dates

Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Jun 14, 2026
Completion
Jun 14, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Safety Lead-in Group)
  • Experimental: Part A, Period 1
  • Experimental: Part A, Period 2
  • Experimental: Part B, Period 1
  • Experimental: Part B, Period 2

Primary Outcome Measure

Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365 [ Time Frame: Up to approximately Day 32 ]

Central Contacts

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

Locations (1)

FacilityCityStateZIPSite coordinators
Syneos Health ClinicMiamiFlorida33136
David Wyatt, Site 0001
305-547-5857

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By research site
Syneos Health Clinic· Miami, FL

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