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 |
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials