Trial | NCT02329184  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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.
Study Started
Dec 31
2014
Primary Completion
Mar 31
2016
Study Completion
Apr 30
2016
Last Update
Sep 14
2016
Estimate

Drug MYK-461

MYK-461 Experimental

Criteria 

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)..
No Results Posted