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The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MYK-461 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYK-461 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of pharmacokinetics parameters as measured by Cmax | maximum concentration (Cmax) | 28 Days |
| Determination of pharmacokinetics parameters as measured by Tmax | time of the maximum measured concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan C Fox, MD, PhD | MyoKardia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85259 | United States | |||
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| 28 Days |
| Determination of pharmacokinetics parameters as measured by AUC | area under the concentration-time curve (AUC) | 28 Days |
| Determination of pharmacokinetics parameters as measured by t1/2 | half-life (t1/2) | 28 Days |
| Cypress |
| California |
| 90630 |
| United States |
| Stanford | California | 94305 | United States |
| Boston | Massachusetts | 02111 | United States |
| Kalamazoo | Michigan | 49007 | United States |
| Durham | North Carolina | 27710 | United States |
| Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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