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
Celgene
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
- Age range
- 18–60 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria * 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 Criteria * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.
Interventions
- DrugBMS-986365
Specified dose on specified days
- DrugItraconazole
Specified dose on specified days
- DrugRifampin
Specified dose on specified days
Location
- Syneos Health ClinicMiami, Florida