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Completed

NCT Number: NCT02356289

Single Ascending Dose Study of MYK-461 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintles LTD

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

MYK-461

Drug

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 28 Days

Secondary outcomes

  1. Determination of pharmacokinetics parameters

    Time frame: 28 Days

    maximum concentration (Cmax)

  2. Determination of pharmacokinetics parameters

    Time frame: 28 Days

    time of the maximum measured concentration (Tmax)

  3. Determination of pharmacokinetics parameters

    Time frame: 28 Days

    area under the concentrationtime curve (AUC)

  4. Determination of pharmacokinetics parameters

    Time frame: 28 Days

    half-life (t1/2)

Sponsors and collaborators

Lead sponsor

MyoKardia, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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