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Completed

NCT Number: NCT02329184

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

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)..

Treatment and study plan

MYK-461

Drug

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 28 Days

Secondary outcomes

  1. Determination of pharmacokinetics parameters as measured by Cmax

    Time frame: 28 Days

    maximum concentration (Cmax)

  2. Determination of pharmacokinetics parameters as measured by Tmax

    Time frame: 28 Days

    time of the maximum measured concentration (Tmax)

  3. Determination of pharmacokinetics parameters as measured by AUC

    Time frame: 28 Days

    area under the concentration-time curve (AUC)

  4. Determination of pharmacokinetics parameters as measured by t1/2

    Time frame: 28 Days

    half-life (t1/2)

Sponsors and collaborators

Lead sponsor

MyoKardia, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2014
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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