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

Bristol-Myers Squibb1 site in 1 country7 target enrollmentJanuary 16, 2023

ConditionsHealthy Volunteers

InterventionsMYK-224

DrugsMYK-224

Overview

Phase: Phase 1
Intervention: MYK-224
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb
Enrollment: 7
Locations: 1
Primary Endpoint: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 16, 2023

End Date

April 8, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Arms & Interventions

MYK-224

Intervention: MYK-224

Outcomes

Primary Outcomes

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

Time Frame: Up to 45 days

Maximum observed concentration (Cmax)

Time Frame: Up to 45 days

Time to maximum observed concentration (Tmax)

Time Frame: Up to 45 days

Secondary Outcomes

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 electrocardiogram (ECG) abnormalities(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 physical examination abnormalities(Up to 45 days)