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.
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
Tullahoma, Tennessee 37388
Principal Investigator: Dinesh Gupta
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Principal Investigator: Michael Koren
Phone: 904-732-9255
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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2301 Erwin Rd
Durham, North Carolina 27710
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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