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NCT Number: NCT02480296

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, Australia

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 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

Treatment and study plan

MYK-461

Drug

Placebo

Drug

Placebo comparator

Primary outcomes

  1. Safety as measured by the incidence of adverse events

    Time frame: 63 days

    Incidence of adverse events

Secondary outcomes

  1. Determination of pharmacokinetic parameters

    Time frame: 63 days

    maximum concentration (Cmax)

  2. Determination of pharmacokinetic parameters

    Time frame: 63 days

    time of the maximum measured concentration (Tmax)

  3. Determination of pharmacokinetic parameters

    Time frame: 63 days

    area under the concentration time curve (AUC)

  4. Determination of pharmacokinetic parameters

    Time frame: 63 days

    half-life (t1/2)

  5. Characterize pharmacodynamic parameters

    Time frame: 63 days

    echocardiogram assessment

  6. Characterize pharmacodynamic parameters

    Time frame: 63 days

    peak oxygen consumption

Sponsors and collaborators

Lead sponsor

MyoKardia, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Mar 22, 2017

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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