Single Ascending Dose Study of MYK-461 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02356289

Enrollment

Registered

2015-02-05

Start date

2015-01-31

Completion date

2015-07-31

Last updated

2015-09-23

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

Conditions

Healthy

Keywords

Hypertrophic Cardiomyopathy

Brief summary

The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, single ascending (oral) dose study in healthy volunteers aged 18-55 years.

Interventions

DRUGPlacebo

DRUGMYK-461

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 not be breastfeeding and must be permanently sterilized or are postmenopausal.

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
Safety: Incidence of adverse events	28 Days

Secondary

Measure	Time frame	Description
Determination of pharmacokinetics parameters	28 Days	maximum concentration (Cmax)

Countries

United Kingdom

Outcome results

None listed

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