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

MyoKardia

Status and phase: Completed; Phase 1

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: MYK-461

Study type: Interventional

Funder types: Industry

Identifiers

NCT02329184

MYK-461-001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)..

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MYK-461

Experimental group

Treatment:

Drug: MYK-461