Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants
- Registration Number
- NCT06417229
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 102
Inclusion Criteria
- Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
- Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.
Exclusion Criteria
- Any significant acute or chronic illness.
- Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds.
- Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Cohort 1 BMS-986365 Dose 1 BMS-986365 - Part 2: Cohort 4 BMS-986365 Dose 10 Fed BMS-986365 - Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 BMS-986365 - Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 Rabeprazole - Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 BMS-986365 - Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 BMS-986365 - Part 1: Cohort 3 BMS-986365 Dose 4 BMS-986365 - Part 1: Cohort 6 BMS-986365 Dose 5 BMS-986365 - Part 1: Cohort 7 BMS-986365 Dose 6 BMS-986365 - Part 1: Cohort 8 BMS-986365 Dose 7 BMS-986365 - Part 1: Cohort 9 BMS-986365 Dose 8 BMS-986365 - Part 2: Cohort 4 BMS-986365 Dose 9 Fasted BMS-986365 -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] Up to Day 75 Maximum observed plasma concentration (Cmax) Up to Day 75 Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] Up to Day 75
- Secondary Outcome Measures
Name Time Method To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation Up to Day 75 Number of participants with vital sign abnormalities Up to Day 75 Number of participants with clinical laboratory abnormalities Up to Day 75 Incidence of serious adverse events (SAE) Up to Day 75 Number of participants with electrocardiogram (ECG) abnormalities Up to Day 75 Incidence of adverse events (AE) Up to Day 75 Number of participants with physical examination abnormalities Up to Day 75
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Lenexa, Kansas, United States