A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants

Phase 1CompletedNCT05981963

Bristol-Myers Squibb8 enrolled

Overview

The purpose of this study is to evaluate the excretion pathway of orally administered \[14C\]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Male Volunteers

Interventions

[14C]-BMS-986196DRUG

Specified dose on specified days

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination. * Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and total body weight ≥ 50 kg Exclusion Criteria: * Any significant acute or chronic medical illness as determined by the investigator. * A history of clinically significant hepatic or pancreatic disease. * Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator. Note: Other protocol-defined inclusion/exclusion criteria apply.

Locations (1)

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)

Time frame: Up to Day 15

TRA: Time of Cmax (Tmax)

Time frame: Up to Day 15

TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

Time frame: Up to Day 15

TRA: Amount of radioactivity recovered in urine (UR)

Time frame: Up to Day 15

TRA: Amount of radioactivity recovered in feces (FR)

Time frame: Up to Day 15

TRA: Amount of radioactivity recovered in bile (BR)

Time frame: Up to 14 hours post dose

TRA: Percent of administered dose recovered in urine (%UR)

Time frame: Up to Day 15

TRA: Percent of administered dose recovered in feces (%FR)

Time frame: Up to Day 15

TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)

Time frame: Up to Day 15

Secondary Outcomes

Cmax

Time frame: Up to Day 15

Tmax

Time frame: Up to Day 15

AUC (0-T)

Data from ClinicalTrials.gov

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