A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Celgene
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Absolute bioavailability (F)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Part A
Intervention: BMS-986365 (Drug)
Part A
Intervention: [14C] BMS-986365 (Drug)
Part B - Arm 1
Intervention: [14C] BMS-986409 + BMS-986410 (Drug)
Part B - Arm 2
Intervention: [14C] BMS-986410 + BMS-986409 (Drug)
Outcomes
Primary Outcomes
Absolute bioavailability (F)
Time Frame: Up to Day 15
Part A
Maximum observed concentration (Cmax)
Time Frame: Up to Day 60
Part A and B
Time of maximum observed concentration (Tmax)
Time Frame: Up to Day 60
Part A and B
Apparent terminal plasma half-life (T-HALF)
Time Frame: Up to Day 60
Part A and B
Total body clearance (CLT)
Time Frame: Up to Day 15
Part A
Apparent total body clearance (CLT/F)
Time Frame: Up to Day 60
Part A and B
Mean residence time (MRT)
Time Frame: Up to Day 15
Part A
Apparent volume of distribution (Vz/F)
Time Frame: 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))
Time Frame: Up to Day 60
Part A and B
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
Time Frame: Up to Day 60
Part A and B
Apparent volume of distribution (Vz)
Time Frame: Up to Day 15
Part A
Secondary Outcomes
- Number of participants with AEs leading to discontinuation(Up to Day 60)
- Number of participants with Serious Adverse Events(Up to Day 60)
- Number of participants with Adverse Events(Up to Day 60)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 60)
- Number of participants with physical examination abnormalities(Up to Day 60)
- Number of participants with Vital sign abnormalities(Up to Day 60)
- Number of participants with clinical laboratory abnormalities(Up to Day 60)