Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491

November 2, 2020 updated by: MyoKardia, Inc.

Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients With Stable Heart Failure With Reduced Ejection Fraction

The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with DCM and stable heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hopital Europeen Georges-Pompidou
  • Germany
      • Berlin, Germany, 10117
        • Charite Research Organization
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Groningen UMC
      • Sneek, Netherlands, 8601
        • D&A Research
  • Poland
      • Wrocław, Poland, 51-124
        • Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologiczny z Pododdzialem Intensywnego Nadzoru Kardiologicznego i Pododdzialem Leczenia Zaburzen Rytmu Serca
      • Łódź, Poland, 93-513
        • Wojewodzki Szpital Specjalistyczny Im M Kopernika
  • Sweden
      • Stockholm, Sweden, 17164
        • Karolinska University Hospital
  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Prism Reseach
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular Cardiology
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Heart and Vascular Center
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Tennessee Center for Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Has stable chronic heart failure with reduced ejection fraction
  • Has adequate acoustic windows for echocardiography

Key Exclusion Criteria:

  • Any significant structural cardiac abnormalities on Screening TTE
  • At Screening, symptomatic hypotension or hypertension or bradycardia.
  • Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators [e.g., nesiritide], diuretics) or routinely scheduled ultrafiltration.
  • Presence of protocol specified laboratory abnormalities at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Part 1/SAD and Part 2/MAD - drug

Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo

Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo
Drug: MYK-491
Single Ascending Dose and Multiple Ascending Dose of MYK-491
Other: Part 1/SAD and Part 2/MAD - placebo

Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo

Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo
Drug: Placebo
Single Ascending Dose and Multiple Ascending Dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of treatment-emergent adverse events and serious adverse events.
Time Frame: Up to 49 days
Up to 49 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MyoKardia, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2018

Primary Completion (Actual)

October 24, 2019

Study Completion (Actual)

October 24, 2019

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYK-491-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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