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

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-60
SponsorCelgene

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Crossover

Treatments tested in this trial

  • BMS-986365

    Drug

    Specified dose on specified days

  • Itraconazole

    Drug

    Specified dose on specified days

  • Rifampin

    Drug

    Specified dose on specified days

Treatment groups

42 Participants
are divided into 5 treatment groups
Group A: Part A (Safety Lead-in Group)Experimental treatment 2 interventions
Group B: Part A, Period 1Experimental treatment 1 intervention
Group C: Part A, Period 2Experimental treatment 2 interventions
Group D: Part B, Period 1Experimental treatment 1 intervention
Group E: Part B, Period 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365

Time frame
Up to approximately Day 32
2

Part A: Cmax of BMS-986365 Without Itraconazole

Time frame
Up to approximately Day 32
3

Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986365 With Itraconazole

Time frame
Up to approximately Day 32
4

Part A: AUC(0-T) of BMS-986365 Without Itraconazole

Time frame
Up to approximately Day 32

Secondary outcomes

1

Number of Participants With Adverse Events (AEs)

Time frame
Up to approximately Day 89
2

Number of Participants With Serious Adverse Events (SAEs)

Time frame
Up to approximately Day 89
3

Number of Participants With AEs Leading to Drug/Study Discontinuation

Time frame
Up to approximately Day 89
4

Number of Participants With Clinically Significant Vital Sign Measurements

Time frame
Up to approximately Day 77

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celgene

Lead sponsor

Source ClinicalTrials.gov
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