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Trial record 65 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

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ClinicalTrials.gov Identifier: NCT03062956
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
MyoKardia, Inc.

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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: MYK-491 or placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Subjects will be randomized 6:2 to MYK-491:placebo within each cohort.
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017


Arm Intervention/treatment
Experimental: Single oral dose of MYK-491
single-dose, oral suspension
Drug: MYK-491 or placebo
Oral suspension

Placebo Comparator: Single oral dose of placebo
single-dose, oral suspension
Drug: MYK-491 or placebo
Oral suspension




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maximum observed plasma drug concentration (Cmax) [ Time Frame: 7 days ]
  2. Maximum observed plasma concentration (Tmax) [ Time Frame: 7 days ]
  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: 7 days ]
  4. First-order terminal elimination half-life (t1/2) [ Time Frame: 7 days ]
  5. Mean retention time (MRT) [ Time Frame: 7 days ]

Other Outcome Measures:
  1. The change from baseline in LVFS, LVEF, LVSV and SET by TTE [ Time Frame: 7 days ]
  2. SET while using photoplethysmography [ Time Frame: 7 days ]
  3. Relationship between MYK-491 plasma concentrations/PK parameters and PD parameters [ Time Frame: 7 days ]
  4. Plasma concentrations of metabolites of MYK-491 in plasma and urine [ Time Frame: 7 days ]
  5. Relationship between MYK-491 plasma concentration and QTc interval [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062956


Locations
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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
MyoKardia, Inc.
Investigators
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Principal Investigator: Jason Lickliter, MD Nucleus Network

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Responsible Party: MyoKardia, Inc.
ClinicalTrials.gov Identifier: NCT03062956     History of Changes
Other Study ID Numbers: MYK-491-001
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly