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

Bristol-Myers Squibb8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Male Participants

Interventions

BMS-986322DRUG

Specified dose on specified days.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Maximum observed in plasma/whole blood concentration (Cmax)

Time frame: Up to day 17

Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time frame: 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))

Time frame: Up to day 17

Time of maximum observed in plasma/whole blood concentration (T-max)

Time frame: Up to day 17

Terminal elimination half-life (T-HALF)

Time frame: Up to day 17

Apparent total body clearance (CL/F)

Time frame: Up to day 17

Apparent volume of distribution of terminal phase (Vz/F)

Time frame: Up to day 17

Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))

Time frame: Up to day 17

Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)

Time frame: Up to day 17

Total amount of radioactivity recovered in urine (UR)

Time frame: Up to day 17

Percent of total amount of radioactivity recovered in urine (%UR)

Time frame: Up to day 17

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of participants with adverse events (AEs)

Time frame: Up to day 47

Number of participants with serious adverse events (SAEs)

Time frame: Up to day 47

Number of participants with AEs leading to discontinuation

Time frame: Up to day 47

Number of participants with vital sign abnormalities

Time frame: Up to day 17

Number of participants with electrocardiogram (ECG) abnormalities

Time frame: Up to day 17

Number of participants with clinically significant physical examination findings

Time frame: Up to day 17

Number of participants with clinical laboratory abnormalities

Time frame: Up to day 17