Healthy Participants
Conditions
Keywords
BMS-986435, MYK-224, Healthy participants, Single-dose
Brief summary
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
Interventions
DRUGBMS-986435
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive. * Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments. * Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.
Exclusion criteria
* Any acute or chronic medical illness. * History of heart disease. * Prior exposure to BMS-986435. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 105 days |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] | Up to 105 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to 105 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to approximately 5 months |
| Incidence of serious adverse events (SAEs) | Up to approximately 5 months |
| Incidence of participants with vital sign abnormalities | Up to 105 days |
| Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)] | Up to 105 days |
| Incidence of participants with electrocardiogram (ECG) abnormalities | Up to 105 days |
| Incidence of participants with clinical laboratory abnormalities | Up to 105 days |
| Incidence of participants with physical examinations abnormalities | Up to 105 days |
| Time of maximum observed concentration [Tmax] | Up to 105 days |
| Apparent terminal half-life [T-HALF] | Up to 105 days |
Countries
United States
Outcome results
None listed