NCT02356289

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2015

Typical duration 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

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

February 2, 2015

Last Update Submit

September 21, 2015

Conditions

Healthy

Keywords

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    28 Days

Secondary Outcomes (4)

  • Determination of pharmacokinetics parameters

    28 Days

  • Determination of pharmacokinetics parameters

    28 Days

  • Determination of pharmacokinetics parameters

    28 Days

  • Determination of pharmacokinetics parameters

    28 Days

Study Arms (2)

MYK-461

EXPERIMENTAL

single-dose, tablet formulation

Drug: MYK-461

Placebo

PLACEBO COMPARATOR

single-dose, tablet formulation

Drug: Placebo

Interventions

PlaceboDRUG
Placebo
MYK-461DRUG
MYK-461

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

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)

Quintles LTD

London, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Jonathan C Fox, MD, PhD

    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

February 2, 2015

First Posted

February 5, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

GB(1)