A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491

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Brief Title

A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491

Official Title

Randomized, Placebo-Controlled Study of Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-491 in Healthy Adult Volunteers

Brief Summary

      Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be
      monitored for safety and tolerability over a 7 day period.
    

Detailed Description

      Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be
      monitored for safety and tolerability over a 7 day period. After the 28 day screening period,
      the eligible subject will be admitted to the clinical site and will receive a single dose of
      study drug or placebo. Subjects will be confined to the clinical site for five days (Day -1
      to Day 4) and will return to the clinic on Day 7 for a safety follow-up.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and tolerability assessments will include treatment emergent AEs and SAEs, ECG recordings, vital signs, hs-troponin 1 concentrations, laboratory abnormalities and physical exam abnormalities

Secondary Outcome

 Maximum observed plasma drug concentration (Cmax)

Condition

Dilated Cardiomyopathy

Intervention

MYK-491 or placebo

Study Arms / Comparison Groups

 Single oral dose of MYK-491
Description:  single-dose, oral suspension

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

64

Start Date

January 16, 2017

Completion Date

November 28, 2017

Primary Completion Date

November 28, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Weight between 60 and 90 kg inclusive

          -  Resting heart rate of < 80 beats per minute

          -  Documented LVEF greater than or equal to 55% during Screening

          -  Normal electrocardiogram (ECG) at Screening

          -  Normal acoustic windows on transthoracic echocardiograms at Screening

          -  All safety laboratory parameters within normal limits at Screening

          -  History or evidence of another clinically significant disorder, in the opinion of the
             investigator.

        Exclusion Criteria:

          -  Active infection

          -  History of coronary artery disease

          -  History of malignancy with the exception of in situ cervical cancer more than 5 years
             prior to Screening or surgically-excised non-melanomatous skin cancers more than 2
             years prior to Screening

          -  Positive serology tests at screening

          -  Current use of tobacco or nicotine-containing products exceeding 10 per day.
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jason Lickliter, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03062956

Organization ID

MYK-491-001


Responsible Party

Sponsor

Study Sponsor

MyoKardia, Inc.


Study Sponsor

Jason Lickliter, MD, Principal Investigator, Nucleus Network


Verification Date

March 2018