Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
Phase 1
Completed
- Conditions
- Hypertrophic Cardiomyopathy
- Interventions
- Drug: MYK-461
- Registration Number
- NCT02329184
- Lead Sponsor
- MyoKardia, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Diagnosed with HCM
- Normal left ventricular ejection fraction (LVEF)
- NYHA class I, II or III
Read More
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)..
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MYK-461 MYK-461 -
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events 28 Days
- Secondary Outcome Measures
Name Time Method Determination of pharmacokinetics parameters as measured by t1/2 28 Days half-life (t1/2)
Determination of pharmacokinetics parameters as measured by Cmax 28 Days maximum concentration (Cmax)
Determination of pharmacokinetics parameters as measured by AUC 28 Days area under the concentration-time curve (AUC)
Determination of pharmacokinetics parameters as measured by Tmax 28 Days time of the maximum measured concentration (Tmax)