Healthy Participants
Conditions
Keywords
MYK-224, Itraconazole, Verapamil
Brief summary
The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.
Interventions
DRUGMYK-224
Specified dose on specified days
DRUGItraconazole
Specified dose on specified days
DRUGVerapamil
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18 and 30 kg/m\^2, inclusive * Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments * Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment * Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing
Exclusion criteria
* Any acute or chronic medical illness * History of dizziness and/or recurrent headaches * History of heart disease Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 36 days |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) | Up to 36 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 36 days |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 36 days |
| Apparent terminal plasma half-life (T-HALF) | Up to 36 days |
| Apparent total body clearance (CLT/F) | Up to 36 days |
| Number of participants with adverse events (AEs) | Up to 52 days |
| Number of participants with serious adverse events (SAEs) | Up to 52 days |
| Number of participants with adverse events leading to discontinuation | Up to 52 days |
| Number of participants with vital sign abnormalities | Up to 52 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 52 days |
| Measurement of left ventricular ejection fraction (LVEF) | Up to 52 days |
| Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI) | Up to 52 days |
| Measurement of left ventricular fractional shortening (LVFS) | Up to 52 days |
| Measurement of left ventricular global longitudinal strain (LV GLS) | Up to 52 days |
| Measurement of left ventricle stroke volume (LVSV) | Up to 52 days |
| Number of participants with physical exam abnormalities | Up to 52 days |
| Number of participants with clinical laboratory abnormalities | Up to 52 days |
Countries
United States
Outcome results
None listed