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

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

Official Title
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A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants

Conditions
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Healthy Male Participants

Intervention / Treatment
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* Drug: BMS-986322


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of BMS-986322<br> | Drug: BMS-986322<br>* Specified dose on specified days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF)) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to day 47 | 
| 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 |