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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 28, 2017

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.

Interventions

  • Drug: MYK-491 or placebo
    • Oral suspension

Arms, Groups and Cohorts

  • Experimental: Single oral dose of MYK-491
    • single-dose, oral suspension
  • Placebo Comparator: Single oral dose of placebo
    • single-dose, oral suspension

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 7 days

Secondary Measures

  • Maximum observed plasma drug concentration (Cmax)
    • Time Frame: 7 days
  • Maximum observed plasma concentration (Tmax)
    • Time Frame: 7 days
  • Area under the plasma concentration-time curve (AUC)
    • Time Frame: 7 days
  • First-order terminal elimination half-life (t1/2)
    • Time Frame: 7 days
  • Mean retention time (MRT)
    • Time Frame: 7 days

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • MyoKardia, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jason Lickliter, MD, Principal Investigator, Nucleus Network

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