Healthy Male Participants
Conditions
Brief summary
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.
Interventions
DRUGBMS-986322
Specified dose on specified days.
Sponsors
Bristol-Myers Squibb
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
* Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive. * Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity * Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.
Exclusion criteria
* Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic. * Participant must not be currently employed in a job requiring radiation exposure monitoring. * Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF)) | Up to day 17 |
| Maximum observed in plasma/whole blood concentration (Cmax) | Up to day 17 |
| Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to day 17 |
| Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to day 17 |
| Time of maximum observed in plasma/whole blood concentration (T-max) | Up to day 17 |
| Terminal elimination half-life (T-HALF) | Up to day 17 |
| Apparent total body clearance (CL/F) | Up to day 17 |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to day 17 |
| Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF) | Up to day 17 |
| Total amount of radioactivity recovered in urine (UR) | Up to day 17 |
| Percent of total amount of radioactivity recovered in urine (%UR) | Up to day 17 |
| Total amount of radioactivity recovered in feces (FR) | Up to day 17 |
| Percent of total amount of radioactivity recovered in feces (%FR) | Up to day 17 |
| Total amount of radioactivity recovered in urine and feces combined (RTotal) | Up to day 17 |
| Percent of total amount of radioactivity recovered in all excreta (%Total) | Up to day 17 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with serious adverse events (SAEs) | Up to day 47 |
| Number of participants with AEs leading to discontinuation | Up to day 47 |
| Number of participants with vital sign abnormalities | Up to day 17 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to day 17 |
| Number of participants with clinically significant physical examination findings | Up to day 17 |
| Number of participants with clinical laboratory abnormalities | Up to day 17 |
| Number of participants with adverse events (AEs) | Up to day 47 |
Countries
United States
Outcome results
None listed