A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of [14C]BMS-986419 in healthy male participants.

Official Title
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A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]BMS-986419


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m^2), inclusive, at screening. Body mass index = weight (kg)/(height [m])2. Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [for example, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -2). Exclusion Criteria: Any significant acute or chronic medical conditions. Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment. Note: Other protocol-defined inclusion/exclusion criteria apply.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]BMS-986419<br> | Drug: [14C]BMS-986419<br>* Specified dose on specified days<br>* Other names: EOAI4018683;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to Day 20 | 
| Time of maximum plasma observed concentration (Tmax) |  | Up to Day 20 | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) |  | Up to Day 20 | 
| Total radioactivity recovered in urine (UR) |  | Up to Day 30 | 
| Total radioactivity recovered in feces (FR) |  | Up to Day 30 | 
| Total radioactivity recovered in bile (BR) |  | Up to Day 30 | 
| Total radioactivity recovered (Rtotal) |  | Up to Day 30 | 
| Percent of total radioactivity recovered (%Total) |  | Up to Day 30 | 
| Percent of total radioactivity recovered in urine (%UR) |  | Up to Day 30 | 
| Percent of total radioactivity recovered in feces (%FR) |  | Up to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Up to Day 60 | 
| Number of Participants with Serious AEs (SAEs) |  | Up to Day 60 | 
| Number of Participants with AEs leading to discontinuation |  | Up to Day 60 | 
| Number of Participants with Vital Sign Abnormalities |  | Up to Day 30 | 
| Number of Participants with Electrocardiogram (ECG) Abnormalities |  | Up to Day 30 | 
| Number of Participants with Physical Examination Abnormalities |  | Up to Day 30 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Up to Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Metabolite profile, Radioactivity, BMS-986419, Healthy volunteer, Healthy participants