Overview

This trial is active, not recruiting.

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
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
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

Male or female 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 August 2016.
Information provided to ClinicalTrials.gov by MyoKardia, Inc..