Clinical Trial: A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 56 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 Summary: Up to 56 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.
Sponsor: MyoKardia, Inc.
Current 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 [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: MyoKardia, Inc.
Dates:
Date Received: February 16, 2017
Date Started: January 16, 2017
Date Completion: July 30, 2017
Last Updated: February 20, 2017
Last Verified: February 2017
