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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329184
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Drug: MYK-461 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Patient Volunteers With Hypertrophic Cardiomyopathy
Study Start Date : December 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: MYK-461 Drug: MYK-461



Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329184


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Cypress, California, United States, 90630
Stanford, California, United States, 94305
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Kalamazoo, Michigan, United States, 49007
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Tennessee
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
MyoKardia, Inc.
Investigators
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Study Director: Jonathan C Fox, MD, PhD MyoKardia, Inc.
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Responsible Party: MyoKardia, Inc.
ClinicalTrials.gov Identifier: NCT02329184    
Other Study ID Numbers: MYK-461-001
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases