Healthy Male Participants Clinical Trial
Official title:
A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants
| Verified date | March 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 22, 2023 |
| Est. primary completion date | December 22, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Fortrea Clinical Research Unit | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed in plasma/whole blood concentration (Cmax) | Up to day 17 | ||
| Primary | Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to day 17 | ||
| Primary | 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 | ||
| Primary | Time of maximum observed in plasma/whole blood concentration (T-max) | Up to day 17 | ||
| Primary | Terminal elimination half-life (T-HALF) | Up to day 17 | ||
| Primary | Apparent total body clearance (CL/F) | Up to day 17 | ||
| Primary | Apparent volume of distribution of terminal phase (Vz/F) | Up to day 17 | ||
| Primary | Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF)) | Up to day 17 | ||
| Primary | Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF) | Up to day 17 | ||
| Primary | Total amount of radioactivity recovered in urine (UR) | Up to day 17 | ||
| Primary | Percent of total amount of radioactivity recovered in urine (%UR) | Up to day 17 | ||
| Primary | Total amount of radioactivity recovered in feces (FR) | Up to day 17 | ||
| Primary | Percent of total amount of radioactivity recovered in feces (%FR) | Up to day 17 | ||
| Primary | Total amount of radioactivity recovered in urine and feces combined (RTotal) | Up to day 17 | ||
| Primary | Percent of total amount of radioactivity recovered in all excreta (%Total) | Up to day 17 | ||
| Secondary | Number of participants with adverse events (AEs) | Up to day 47 | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to day 47 | ||
| Secondary | Number of participants with AEs leading to discontinuation | Up to day 47 | ||
| Secondary | Number of participants with vital sign abnormalities | Up to day 17 | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to day 17 | ||
| Secondary | Number of participants with clinically significant physical examination findings | Up to day 17 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to day 17 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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