Safety, Tolerability, Pharmacokinetics and Pharmacodynami... | NCT02480296

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

NCT02480296

Sponsor

MyoKardia, Inc.

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

60Actual

Phase

Phase 1

Conditions

Healthy

Interventions

MYK-461
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jun 17, 2015

First Submission Date that Met QC Criteria

Jun 22, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MYK-461	Experimental	Oral Tablet x 28 days	Drug: MYK-461
Placebo	Placebo Comparator	Oral Tablet x 28 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MYK-461	Drug		MYK-461
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as measured by the incidence of adverse events	Incidence of adverse events	63 days

Secondary Outcomes

Measure	Description	Time Frame
Determination of pharmacokinetic parameters	maximum concentration (Cmax)	63 days
Determination of pharmacokinetic parameters	time of the maximum measured concentration (Tmax)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Grimm, MD	MyoKardia, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network		Melbourne	Victoria		Australia

Intervention Browse Module

MeSH Terms

ID	Term
C000605992	MYK-461

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided