NCT02480296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

June 17, 2015

Last Update Submit

March 21, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by the incidence of adverse events

    Incidence of adverse events

    63 days

Secondary Outcomes (6)

  • Determination of pharmacokinetic parameters

    63 days

  • Determination of pharmacokinetic parameters

    63 days

  • Determination of pharmacokinetic parameters

    63 days

  • Determination of pharmacokinetic parameters

    63 days

  • Characterize pharmacodynamic parameters

    63 days

  • +1 more secondary outcomes

Study Arms (2)

MYK-461

EXPERIMENTAL

Oral Tablet x 28 days

Drug: MYK-461

Placebo

PLACEBO COMPARATOR

Oral Tablet x 28 days

Drug: Placebo

Interventions

MYK-461DRUG
MYK-461
PlaceboDRUG

Placebo comparator

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any structural abnormalities on echocardiography
  • Positive results of HIV test and/or seropositive for HCV or HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Victoria, Australia

Location

MeSH Terms

Interventions

MYK-461

Study Officials

  • Michael Grimm, MD

    MyoKardia, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

AU(1)