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

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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
7
sites
Columbus, Ohio 43210
Principal Investigator: Ray Hershberger
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Principal Investigator: Michael Koren
Phone: 904-732-9255
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Jacksonville, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Samuel Camacho
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Ravi Karra
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Anjali Owens
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Philadelphia, PA
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Saint Paul, Minnesota 55102
Principal Investigator: Les Forgosh
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Tullahoma, Tennessee 37388
Principal Investigator: Dinesh Gupta
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Tullahoma, TN
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