Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Metabolite profile, Radioactivity, BMS-986419, Healthy volunteer, Healthy participants
Brief summary
The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of \[14C\]BMS-986419 in healthy male participants.
Interventions
DRUG[14C]BMS-986419
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m\^2), inclusive, at screening. Body mass index = weight (kg)/(height \[m\])2. * Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[for example, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -2).
Exclusion criteria
* Any significant acute or chronic medical conditions. * Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). * Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of total radioactivity recovered in feces (%FR) | Up to Day 30 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to Day 20 |
| Total radioactivity recovered in urine (UR) | Up to Day 30 |
| Total radioactivity recovered in feces (FR) | Up to Day 30 |
| Total radioactivity recovered in bile (BR) | Up to Day 30 |
| Total radioactivity recovered (Rtotal) | Up to Day 30 |
| Percent of total radioactivity recovered (%Total) | Up to Day 30 |
| Percent of total radioactivity recovered in urine (%UR) | Up to Day 30 |
| Maximum observed plasma concentration (Cmax) | Up to Day 20 |
| Time of maximum plasma observed concentration (Tmax) | Up to Day 20 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Serious AEs (SAEs) | Up to Day 60 |
| Number of Participants with AEs leading to discontinuation | Up to Day 60 |
| 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 Physical Examination Abnormalities | Up to Day 30 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 30 |
| Number of Participants with Adverse Events (AEs) | Up to Day 60 |
Countries
United States
Outcome results
None listed