v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
NCT ID: NCT03447990
Last Updated: 2023-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2018-02-06
2019-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The second part is a randomized, parallel, double-blind, placebo-controlled, sequential ascending multiple dose study. All patients will receive placebo and/or active doses of MYK-491.
TREATMENT
QUADRUPLE
Study Groups
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Part 1/SAD and Part 2/MAD - drug
Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo
Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo
MYK-491
Single Ascending Dose and Multiple Ascending Dose of MYK-491
Part 1/SAD and Part 2/MAD - placebo
Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo
Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo
Placebo
Single Ascending Dose and Multiple Ascending Dose of placebo
Interventions
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MYK-491
Single Ascending Dose and Multiple Ascending Dose of MYK-491
Placebo
Single Ascending Dose and Multiple Ascending Dose of placebo
Eligibility Criteria
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Inclusion Criteria
* Has adequate acoustic windows for echocardiography
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Locations
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Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Prism Reseach
Saint Paul, Minnesota, United States
St. Louis Heart and Vascular Cardiology
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania Heart and Vascular Center
Philadelphia, Pennsylvania, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Hopital Europeen Georges-Pompidou
Paris, , France
Charite Research Organization
Berlin, , Germany
Groningen UMC
Groningen, , Netherlands
D&A Research
Sneek, , Netherlands
Wojewodzki Szpital Specjalistyczny Im M Kopernika
Lodz, , Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologiczny z Pododdzialem Intensywnego Nadzoru Kardiologicznego i Pododdzialem Leczenia Zaburzen Rytmu Serca
Wroclaw, , Poland
Karolinska University Hospital
Stockholm, , Sweden
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MYK-491-003
Identifier Type: -
Identifier Source: org_study_id
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