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

Status:	Recruiting
Conditions:	Cardiology, Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 80
Updated:	3/8/2019
Start Date:	February 6, 2018
End Date:	December 2019
Contact:	MyoKardia Medical Affairs
Email:	medinfo@myokardia.com
Phone:	650-741-0900

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.

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.

We found this trial at

sites

Oregon Health and Science University

3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239

503 494-8311