Healthy Volunteers
Conditions
Keywords
ADME, Healthy male volunteers, Pharmacokinetics, BMS-986368, CC-97489
Brief summary
The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.
Interventions
DRUG[14C]-BMS-986368
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator. * Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height\[m\])\^2
Exclusion criteria
* History of hypokalemia. * Any significant acute or chronic medical illness as determined by the investigator. * Participant has a history of syncope in the year prior to Day 1. Other protocol-defined incusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of maximum observed concentration (Tmax) | Up to Day 15 |
| Maximum observed concentration (Cmax) | Up to Day 15 |
| Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 15 |
| Total Radioactivity (TRA) | Up to Day 30 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with vital sign abnormalities | Up to Day 30 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 30 |
| Number of participants with Serious AEs (SAEs) | Up to Day 36 |
| Number of participants with Adverse Events (AEs) | Up to Day 36 |
| Number of participants with physical examination abnormalities | Up to Day 30 |
| Number of participants with clinical laboratory test abnormalities | Up to Day 30 |
| Number of participants with AEs leading to discontinuation | Up to Day 36 |
Countries
United States
Outcome results
None listed