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

Celgene

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Itraconazole; Drug: BMS-986365; Drug: Rifampin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07242781

CA071-1006

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

Part A (Safety Lead-in Group)

Experimental group

Treatment:

Drug: BMS-986365

Drug: Itraconazole

Part A, Period 1

Experimental group

Treatment:

Drug: BMS-986365

Part A, Period 2

Experimental group

Treatment:

Drug: BMS-986365

Drug: Itraconazole

Part B, Period 1

Experimental group

Treatment:

Drug: BMS-986365

Part B, Period 2

Experimental group

Treatment:

Drug: Rifampin

Drug: BMS-986365