Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461



Status:Active, not recruiting
Conditions:High Cholesterol, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:December 2014
End Date:April 2016

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Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Patient Volunteers With Hypertrophic Cardiomyopathy

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.


Inclusion Criteria:

- Diagnosed with HCM

- Normal left ventricular ejection fraction (LVEF)

- NYHA class I, II or III

Exclusion Criteria:

- Inherited metabolic disorders, myocardial infiltration or cardiofaciocutaneous
syndrome (e.g., Noonan's, Fabry's).

- History of clinically important atrial or ventricular arrhythmias

- History of positive human immunodeficiency virus (HIV) test and/or seropositive for
hepatitis C virus (HCV) or hepatitis B virus (HBV)..
We found this trial at
7
sites
1840
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from 91732
Kalamazoo, MI
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2578
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from 91732
Boston, MA
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17
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from 91732
Cypress, CA
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2202
mi
from 91732
Durham, NC
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1763
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from 91732
Nashville, TN
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352
mi
from 91732
Scottsdale, AZ
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328
mi
from 91732
Stanford, CA
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