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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02329184

Enrollment

Registered

2014-12-31

Start date

2014-12-31

Completion date

2016-04-30

Last updated

2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

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.

Interventions

DRUGMYK-461

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)..

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	28 Days

Secondary

Measure	Time frame	Description
Determination of pharmacokinetics parameters as measured by Cmax	28 Days	maximum concentration (Cmax)
Determination of pharmacokinetics parameters as measured by Tmax	28 Days	time of the maximum measured concentration (Tmax)
Determination of pharmacokinetics parameters as measured by AUC	28 Days	area under the concentration-time curve (AUC)
Determination of pharmacokinetics parameters as measured by t1/2	28 Days	half-life (t1/2)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026