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

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

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 Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Itraconazole; Drug: Rifampin; Drug: BMS-986365

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain the NCT# and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Syneos Health clinic
      • Contact: David Wyatt, Site 0001; Phone Number: 305-547-5857

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (Safety Lead-in Group)	Drug: Itraconazole; Specified dose on specified days; Other Names: SPORANOX®; Drug: BMS-986365; Specified dose on specified days; Other Names: AR-LDD, CC-94676
Experimental: Part A, Period 1	Drug: BMS-986365; Specified dose on specified days; Other Names: AR-LDD, CC-94676
Experimental: Part A, Period 2	Drug: Itraconazole; Specified dose on specified days; Other Names: SPORANOX®; Drug: BMS-986365; Specified dose on specified days; Other Names: AR-LDD, CC-94676
Experimental: Part B, Period 1	Drug: BMS-986365; Specified dose on specified days; Other Names: AR-LDD, CC-94676
Experimental: Part B, Period 2	Drug: Rifampin; Specified dose on specified days; Drug: BMS-986365; Specified dose on specified days; Other Names: AR-LDD, CC-94676

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Laboratory safety tests include hematology, chemistry, and urinalysis.	Up to approximately Day 77
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities		Up to approximately Day 77
Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities		Up to approximately Day 77
Change From Baseline of Corrected QT Interval (QTc) Post Dose of BMS-986365		Up to approximately Day 77
Part A: Change From Baseline of QTc Post Dose of BMS-986365 With Itaconazole		Up to approximately Day 72
Part B: Change From Baseline of QTc Post Dose of BMS-986365 With Rifampin		Up to approximately Day 77
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986365		Up to approximately Day 77
Apparent Terminal Plasma Half-life (T-HALF) of BMS-986365		Up to approximately Day 77
Apparent Total Body Clearance (CLT/F) of BMS-986365		Up to approximately Day 77
Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986365		Up to approximately Day 77

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Crossover; Open-label; Healthy male volunteers; Itraconazole; Rifampin; CC-94676; BMS-986365
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Rifamycins; Lactams, Macrocyclic; Macrocyclic Compounds; Triazoles; Piperazines; Rifampin; Itraconazole
• Other Study ID Numbers: CA071-1006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No