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

Brief Title

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

Official Title

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

Brief Summary

      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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Frequency and severity of treatment-emergent adverse events and serious adverse events.

Condition

Dilated Cardiomyopathy

Intervention

MYK-491

Study Arms / Comparison Groups

 Part 1/SAD and Part 2/MAD - drug

Description:  Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo
Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

52

Start Date

February 6, 2018

Completion Date

October 24, 2019

Primary Completion Date

October 24, 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

France

Location Countries

France

NCT ID

NCT03447990

Organization ID

MYK-491-003

Responsible Party

Sponsor

Study Sponsor

MyoKardia, Inc.

Study Sponsor

, , 

Verification Date

December 2019