RecruitingPhase 1NCT07242781
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants
A Phase 1, Open-label, 2-part, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of AR-LDD (BMS-986365) in Healthy Adult Male Participants
Sponsor
Celgene
Enrollment
42 participants
Start Date
Dec 15, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: MALEMin Age: 18 YearsMax Age: 60 Years
Inclusion Criteria1
- Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.
Exclusion Criteria2
- Participants must not have any significant or chronic illness.
- Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
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Interventions
DRUGBMS-986365
Specified dose on specified days
DRUGItraconazole
Specified dose on specified days
DRUGRifampin
Specified dose on specified days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07242781
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