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

MyoKardia, Inc.1 site in 1 country60 target enrollmentAugust 2015

ConditionsHealthy

InterventionsMYK-461 Placebo

DrugsMYK-461 Placebo

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 Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MyoKardia, Inc.

Responsible Party

Sponsor

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