CompletedNCT02480296Updated Mar 22, 2017

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

A Phase 1 interventional study of MYK-461 and Placebo in Healthy, sponsored by MyoKardia, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by MyoKardia, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Healthy

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 60 participants (actual)

Study arms

Experimental
MYK-461
Oral Tablet x 28 days
Drug: MYK-461
Placebo comparator
Placebo
Oral Tablet x 28 days
Drug: Placebo

Interventions

DrugMYK-461
DrugPlacebo
Placebo comparator

What researchers measure

Primary outcomes

Safety as measured by the incidence of adverse events
Incidence of adverse events
Time frame: 63 days

Secondary outcomes

Determination of pharmacokinetic parameters
maximum concentration (Cmax)
Time frame: 63 days
Determination of pharmacokinetic parameters
time of the maximum measured concentration (Tmax)
Time frame: 63 days
Determination of pharmacokinetic parameters
area under the concentration time curve (AUC)
Time frame: 63 days
Determination of pharmacokinetic parameters
half-life (t1/2)
Time frame: 63 days
Characterize pharmacodynamic parameters
echocardiogram assessment
Time frame: 63 days
Characterize pharmacodynamic parameters
peak oxygen consumption
Time frame: 63 days

Study locations

1 site

Nucleus Network
Melbourne, Victoria, Australia

Registry details

Key details

Study ID: NCT02480296
Lead sponsor: MyoKardia, Inc.
Responsible party: Sponsor
First posted: Jun 24, 2015
Start date: Aug 2015
Primary completion: Jul 2016
Completion: Oct 2016
Last update: Mar 22, 2017

Study contacts

Michael Grimm, MD

study director · MyoKardia, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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