Healthy Volunteers
Conditions
Keywords
Absorption, Metabolism, and Excretion (ADME), MYK-224
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.
Interventions
DRUGMYK-224
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Number of participants with vital sign abnormalities | Up to 45 days |
| Metabolite profiling of BMS-986435 in plasma, urine, and feces | Up to 45 days |
| Number of participants with physical examination abnormalities | Up to 45 days |
| Number of participants with electrocardiogram (ECG) abnormalities | 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 |
Countries
United States
Outcome results
None listed