NCT02480296
Completed
Phase 1
A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple Oral Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-461 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- MYK-461
- Conditions
- Healthy
- Sponsor
- MyoKardia, Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Safety as measured by the incidence of adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal body mass index (BMI)
- •Normal LVEF
- •Normal electrocardiogram (ECG)
- •Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug
Exclusion Criteria
- •Any structural abnormalities on echocardiography
- •Positive results of HIV test and/or seropositive for HCV or HBV
Arms & Interventions
MYK-461
Oral Tablet x 28 days
Intervention: MYK-461
Placebo
Oral Tablet x 28 days
Intervention: Placebo
Outcomes
Primary Outcomes
Safety as measured by the incidence of adverse events
Time Frame: 63 days
Incidence of adverse events
Secondary Outcomes
- Determination of pharmacokinetic parameters(63 days)
- Characterize pharmacodynamic parameters(63 days)
Study Sites (1)
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