Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavacamten- Dose A | Experimental |
| |
| Mavacamten- Dose B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to approximately 1 month | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) | Up to approximately 1 month | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) | Up to approximately 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to approximately 1 month | |
| Terminal half-life (T-HALF) | Up to approximately 1 month | |
| Number of participants with adverse events (AEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Advanced Pharma CR, LLC |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
Not provided
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605992 | MYK-461 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to approximately 1 month |
| Number of participants with serious adverse events (SAEs) | Up to approximately 1 month |
| Number of participants with vital sign abnormalities exceeding predefined thresholds | Up to approximately 1 month |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to approximately 1 month |
| Number of participants with physical exam abnormalities | Up to approximately 1 month |
| Number of participants with clinical laboratory evaluation abnormalities | Up to approximately 1 month |
| Miami |
| Florida |
| 33147 |
| United States |
| QPS Springfield | Springfield | Missouri | 65802 | United States |
| Ppd Phase I Clinic | Austin | Texas | 78744 | United States |
| FDA Safety Alerts and Recalls | View source |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |