Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02480296

Enrollment

Registered

2015-06-24

Start date

2015-08-31

Completion date

2016-10-31

Last updated

2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGMYK-461

DRUGPlacebo

Placebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety as measured by the incidence of adverse events	63 days	Incidence of adverse events

Secondary

Measure	Time frame	Description
Determination of pharmacokinetic parameters	63 days	maximum concentration (Cmax)
Characterize pharmacodynamic parameters	63 days	echocardiogram assessment

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026