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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: MYK-224 | Experimental |
| |
| Arm 2: MYK-224 + Itraconazole | Experimental |
| |
| Arm 3: MYK-224 + Verapamil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYK-224 | Drug | Specified dose on specified days |
|
| Measure | Description | 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 |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Dallas | Texas | 75247 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Specified dose on specified days |
|
| Verapamil | Drug | Specified dose on specified days |
|
| 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 |
| D010879 |
| Piperazines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |