Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: MYK-461Drug: Placebo
- Registration Number
- NCT02480296
- Lead Sponsor
- MyoKardia, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
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Exclusion Criteria
- Any structural abnormalities on echocardiography
- Positive results of HIV test and/or seropositive for HCV or HBV
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MYK-461 MYK-461 Oral Tablet x 28 days Placebo Placebo Oral Tablet x 28 days
- Primary Outcome Measures
Name Time Method Safety as measured by the incidence of adverse events 63 days Incidence of adverse events
- Secondary Outcome Measures
Name Time Method Determination of pharmacokinetic parameters 63 days half-life (t1/2)
Characterize pharmacodynamic parameters 63 days peak oxygen consumption
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Melbourne, Victoria, Australia