Overview

This trial has been completed.

Condition healthy
Treatments myk-461, placebo
Phase phase 1
Sponsor MyoKardia, Inc.
Start date August 2015
End date July 2016
Trial size 60 participants
Trial identifier NCT02480296, MYK461-003

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator
Arm
(Experimental)
Oral Tablet x 28 days
myk-461
(Placebo Comparator)
Oral Tablet x 28 days
placebo
Placebo comparator

Primary Outcomes

Measure
Safety as measured by the incidence of adverse events
time frame: 63 days

Secondary Outcomes

Measure
Determination of pharmacokinetic parameters
time frame: 63 days
Determination of pharmacokinetic parameters
time frame: 63 days
Determination of pharmacokinetic parameters
time frame: 63 days
Determination of pharmacokinetic parameters
time frame: 63 days
Characterize pharmacodynamic parameters
time frame: 63 days
Characterize pharmacodynamic parameters
time frame: 63 days

Eligibility Criteria

All participants from 18 years up to 55 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by MyoKardia, Inc..