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

Phase 1RecruitingNCT07242781

Celgene42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

BMS-986365DRUG

Specified dose on specified days

ItraconazoleDRUG

Specified dose on specified days

RifampinDRUG

Specified dose on specified days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Syneos Health Clinic

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Up to approximately Day 32

Part A: Cmax of BMS-986365 Without Itraconazole

Time frame: Up to approximately Day 32

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

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

Time frame: Up to approximately Day 32

Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986365

Time frame: Up to approximately Day 32

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

Time frame: Up to approximately Day 32

Part B: Cmax of BMS-986365 With Rifampin

Time frame: Up to approximately Day 37

Part B: Cmax of BMS-986365 Without Rifampin

Time frame: Up to approximately Day 37

Part B: AUC(INF) of BMS-986365 With Rifampin

Time frame: Up to approximately Day 37

Part B: AUC(INF) of BMS-986365 Without Rifampin

Time frame: Up to approximately Day 37

Part B: AUC(0-T) of BMS-986365 With Rifampin

Time frame: Up to approximately Day 37

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Participants With Adverse Events (AEs)

Time frame: Up to approximately Day 89

Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to approximately Day 89

Number of Participants With AEs Leading to Drug/Study Discontinuation

Time frame: Up to approximately Day 89

Number of Participants With Clinically Significant Vital Sign Measurements