Healthy Volunteers
Conditions
Keywords
Healthy male volunteers, BMS-986365, CC-94676, Itraconazole, Rifampin, Pharmacokinetics, Crossover, Open-label
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.
Interventions
DRUGBMS-986365
Specified dose on specified days
DRUGItraconazole
Specified dose on specified days
DRUGRifampin
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed