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CompletedNCT02329184Updated Sep 14, 2016

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

A Phase 1 interventional study of MYK-461 in Hypertrophic Cardiomyopathy, sponsored by MyoKardia, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-14.

Sponsored by MyoKardia, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with HCM
  • Normal left ventricular ejection fraction (LVEF)
  • NYHA class I, II or III

Exclusion criteria

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)..
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    MYK-461

    Drug: MYK-461

Interventions

  • DrugMYK-461
05

What researchers measure

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 28 Days

Secondary outcomes

  1. Determination of pharmacokinetics parameters as measured by Cmax

    maximum concentration (Cmax)

    Time frame: 28 Days

  2. Determination of pharmacokinetics parameters as measured by Tmax

    time of the maximum measured concentration (Tmax)

    Time frame: 28 Days

  3. Determination of pharmacokinetics parameters as measured by AUC

    area under the concentration-time curve (AUC)

    Time frame: 28 Days

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

    half-life (t1/2)

    Time frame: 28 Days

06

Study locations

7 sites
  • Scottsdale, Arizona 85259, United States
  • Cypress, California 90630, United States
  • Stanford, California 94305, United States
  • Boston, Massachusetts 02111, United States
  • Kalamazoo, Michigan 49007, United States
  • Durham, North Carolina 27710, United States
  • Nashville, Tennessee 37232, United States
07

Registry details

Key details

Study ID
NCT02329184
Lead sponsor
MyoKardia, Inc.
Responsible party
Sponsor
First posted
Dec 31, 2014
Start date
Dec 2014
Primary completion
Mar 2016
Completion
Apr 2016
Last update
Sep 14, 2016

Study contacts

Jonathan C Fox, MD, PhD
study director · MyoKardia, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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