A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435

Study Overview
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Brief Summary
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The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants Participants will be admitted to the study site for 3 weeks.

Official Title
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A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: MYK-224


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Body mass index between 18 and 32 kg/m^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor. Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE. Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening. Key Exclusion Criteria: Any acute or chronic medical illness. History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration). Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MYK-224<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | Up to 45 days | 
| Time to maximum observed concentration (Tmax) |  | Up to 45 days | 
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) |  | Up to 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite profiling of BMS-986435 in plasma, urine, and feces |  | Up to 45 days | 
| Number of participants with adverse events (AEs) |  | Up to 45 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 45 days | 
| Number of participants with vital sign abnormalities |  | Up to 45 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 45 days | 
| Number of participants with physical examination abnormalities |  | Up to 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absorption, Metabolism, and Excretion (ADME), MYK-224