A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants

Phase 1

Completed

• Conditions: Healthy Male Participants
• Interventions: Drug: BMS-986322

• Registration Number: NCT06088264
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2023-10-31
• Primary Completion: 2023-12-22
• Study Completion: 2023-12-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of BMS-986322	BMS-986322	-

Primary Outcome Measures

Name	Time	Method
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
Time of maximum observed in plasma/whole blood concentration (T-max)	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
Apparent total body clearance (CL/F)	Up to day 17
Apparent volume of distribution of terminal phase (Vz/F)	Up to day 17
Percent of total amount of radioactivity recovered in urine (%UR)	Up to day 17
Percent of total amount of radioactivity recovered in feces (%FR)	Up to day 17
Terminal elimination half-life (T-HALF)	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
Total amount of radioactivity recovered in feces (FR)	Up to day 17
Percent of total amount of radioactivity recovered in all excreta (%Total)	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
Total amount of radioactivity recovered in urine and feces combined (RTotal)	Up to day 17

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious adverse events (SAEs)	Up to day 47
Number of participants with electrocardiogram (ECG) abnormalities	Up to day 17
Number of participants with clinical laboratory abnormalities	Up to day 17
Number of participants with clinically significant physical examination findings	Up to day 17
Number of participants with adverse events (AEs)	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

Trial Locations

Locations (1)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States