A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: [14C] BMS-986409 + BMS-986410Drug: [14C] BMS-986410 + BMS-986409Drug: [14C] BMS-986365
- Registration Number
- NCT06433505
- Lead Sponsor
- Celgene
- Brief Summary
The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
- Participants will require a left ventricular ejection fraction of > 50% at screening.
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height [m])2.
Exclusion Criteria
- Any current or recent significant acute or chronic illness.
- Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (> 450 ms) at screening.
- Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
- History of allergy to BMS-986365 or related compounds.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B - Arm 1 [14C] BMS-986409 + BMS-986410 - Part B - Arm 2 [14C] BMS-986410 + BMS-986409 - Part A BMS-986365 - Part A [14C] BMS-986365 -
- Primary Outcome Measures
Name Time Method Absolute bioavailability (F) Up to Day 15 Part A
Maximum observed concentration (Cmax) Up to Day 60 Part A and B
Time of maximum observed concentration (Tmax) Up to Day 60 Part A and B
Apparent terminal plasma half-life (T-HALF) Up to Day 60 Part A and B
Total body clearance (CLT) Up to Day 15 Part A
Apparent total body clearance (CLT/F) Up to Day 60 Part A and B
Mean residence time (MRT) Up to Day 15 Part A
Apparent volume of distribution (Vz/F) Up to Day 60 Part A and B
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Up to Day 60 Part A and B
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF)) Up to Day 60 Part A and B
Apparent volume of distribution (Vz) Up to Day 15 Part A
- Secondary Outcome Measures
Name Time Method Number of participants with AEs leading to discontinuation Up to Day 60 Part A and B
Number of participants with Serious Adverse Events Up to Day 60 Part A and B
Number of participants with Adverse Events Up to Day 60 Part A and B
Number of participants with electrocardiogram (ECG) abnormalities Up to Day 60 Part A and B
Number of participants with physical examination abnormalities Up to Day 60 Part A and B
Number of participants with Vital sign abnormalities Up to Day 60 Part A and B
Number of participants with clinical laboratory abnormalities Up to Day 60 Part A and B
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Madison, Wisconsin, United States