Healthy Volunteers
Conditions
Keywords
BMS-986365, Pharmacokinetics, Absolute Bioavailability, Healthy Male Volunteers, CC-94676, ADME
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.
Interventions
DRUGBMS-986365
Specified dose on specified days
DRUG[14C] BMS-986365
Specified dose on specified days.
DRUG[14C] BMS-986409 + BMS-986410
Specified dose on specified days
DRUG[14C] BMS-986410 + BMS-986409
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute bioavailability (F) | Up to Day 15 | Part A |
| 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 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) | Up to Day 15 | Part A |
| Apparent volume of distribution (Vz/F) | Up to Day 60 | Part A and B |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Serious Adverse Events | Up to Day 60 | Part A and B |
| Number of participants with AEs leading to discontinuation | 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 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 clinical laboratory abnormalities | Up to Day 60 | Part A and B |
| Number of participants with Adverse Events | Up to Day 60 | Part A and B |
Countries
United States
Outcome results
None listed