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 Information
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
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03447990
Organization ID
MYK-491-003
Responsible Party
Sponsor
Study Sponsor
MyoKardia, Inc.
Study Sponsor
, ,
Verification Date
December 2019