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The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavacamten Dose 1 | Experimental |
| |
| Mavacamten Dose 2 | 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) | Predose and post-dose up to Day 80 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Predose and post-dose up to Day 80 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF]) | Predose and post-dose up to Day 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Predose and post-dose up to Day 80 | |
| Terminal Half-life (T-Half) | Predose and post-dose up to Day 80 | |
| Number of Participants with Adverse Events (AEs) |
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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 | Miami | Florida | 33136 | 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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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D006984 | Hypertrophy |
| D000092242 | Ventricular Outflow Obstruction, Left |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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| Up to Day 80 |
| Number of Participants with Serious AEs (SAEs) | Up to Day 80 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 80 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to Day 80 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 80 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 80 |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| D006349 | Heart Valve Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014694 | Ventricular Outflow Obstruction |