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The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
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| Sequence 3 | Experimental |
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| Sequence 4 | Experimental |
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| Sequence 5 | Experimental |
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| Sequence 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten Capsule 1 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | From Day 1 up to Day 35±2 of each period | |
| Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] | From Day 1 up to Day 35±2 of each period | |
| Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] | From Day 1 up to Day 35±2 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)] | From Day 1 to Day 4 of each period | |
| Time of Maximum Observed Serum Concentration (Tmax) | From Day 1 up to Day 35±2 of each period |
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Inclusion Criteria:
Exclusion Criteria:
Note: 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 | Anaheim | California | 92801 | United States | ||
| Local Institution - 0002 |
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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 |
|---|---|
| C000605992 | MYK-461 |
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| Mavacamten Capsule 2 | Drug | Specified dose on specified days |
|
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| Mavacamten Capsule 3 | Drug | Specified dose on specified days |
|
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| Terminal Half-life (T-HALF) | From Day 1 up to Day 35±2 of each period |
| Number of Participants with Adverse Events (AEs) | Up to 35 days post discontinuation of dosing |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 35 days post discontinuation of dosing |
| Number of Participants with Vital Sign Abnormalities | Up to 35 days post discontinuation of dosing |
| Number of Participants with Electrocardiograms (ECG) Abnormalities | Up to 35 days post discontinuation of dosing |
| Number of Participants with Physical Examination Abnormalities | Up to 35 days post discontinuation of dosing |
| Number of Participants with Clinical Laboratory Evaluation Abnormalities | Up to 35 days post discontinuation of dosing |
| Miami |
| Florida |
| 33126 |
| United States |
| Local Institution - 0003 | Springfield | Missouri | 65802 | United States |