A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435
- Registration Number
- NCT05686096
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MYK-224 MYK-224 -
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) Up to 45 days Maximum observed concentration (Cmax) Up to 45 days Time to maximum observed concentration (Tmax) Up to 45 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Madison, Wisconsin, United States