A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants
Not Applicable
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT07242781
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A (Safety Lead-in Group) BMS-986365 - Part A, Period 1 BMS-986365 - Part A (Safety Lead-in Group) Itraconazole - Part A, Period 2 Itraconazole - Part B, Period 1 BMS-986365 - Part A, Period 2 BMS-986365 - Part B, Period 2 BMS-986365 - Part B, Period 2 Rifampin -
- Primary Outcome Measures
Name Time Method Part A: Cmax of BMS-986365 Without Itraconazole 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 Without Rifampin Up to approximately Day 37 Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365 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: 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 B: Cmax 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 Without Rifampin Up to approximately Day 37 Part A: AUC(0-T) of BMS-986365 Without Itraconazole Up to approximately Day 32 Part B: AUC(0-T) of BMS-986365 With Rifampin Up to approximately Day 37 Part B: AUC(INF) of BMS-986365 With Rifampin Up to approximately Day 37
- Secondary Outcome Measures
Name Time Method 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 Laboratory safety tests include hematology, chemistry, and urinalysis.
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities 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 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 Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986365 Up to approximately Day 77