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

NCT07242781 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CA071-1006
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy male volunteers; BMS-986365; CC-94676; Itraconazole; Rifampin; Pharmacokinetics; Crossover; Open-label

Outcome Measures

Primary Outcomes (12)

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

  Up to approximately Day 32

• Part A: Cmax of BMS-986365 Without Itraconazole

  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

  Up to approximately Day 32

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

  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

  Up to approximately Day 32

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

  Up to approximately Day 32

• Part B: Cmax of BMS-986365 With Rifampin

  Up to approximately Day 37

• Part B: Cmax of BMS-986365 Without Rifampin

  Up to approximately Day 37

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

  Up to approximately Day 37

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

  Up to approximately Day 37

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

  Up to approximately Day 37

• Part B: AUC(0-T) of BMS-986365 Without Rifampin

  Up to approximately Day 37

Secondary Outcomes (14)

• Number of Participants With Adverse Events (AEs)

  Up to approximately Day 89

• Number of Participants With Serious Adverse Events (SAEs)

  Up to approximately Day 89

• Number of Participants With AEs Leading to Drug/Study Discontinuation

  Up to approximately Day 89

• Number of Participants With Clinically Significant Vital Sign Measurements

  Up to approximately Day 77

• Number of Participants With Clinically Significant Laboratory Safety Tests

  Up to approximately Day 77

Study Arms (5)

Part A (Safety Lead-in Group)

EXPERIMENTAL

Drug: BMS-986365; Drug: Itraconazole

Part A, Period 1

EXPERIMENTAL

Drug: BMS-986365

Part A, Period 2

EXPERIMENTAL

Drug: BMS-986365; Drug: Itraconazole

Part B, Period 1

EXPERIMENTAL

Drug: BMS-986365

Part B, Period 2

EXPERIMENTAL

Drug: BMS-986365; Drug: Rifampin

Interventions

BMS-986365 DRUG

Specified dose on specified days

Also known as: AR-LDD, CC-94676

Part A (Safety Lead-in Group); Part A, Period 1; Part A, Period 2; Part B, Period 1; Part B, Period 2

Itraconazole DRUG

Specified dose on specified days

Also known as: SPORANOX®

Part A (Safety Lead-in Group); Part A, Period 2

Rifampin DRUG

Specified dose on specified days

Part B, Period 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Syneos Health Clinic

Miami, Florida, 33136, United States

RECRUITING

Related Links

• BMS Clinical Trial Information

MeSH Terms

Interventions

Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)