A Phase 1 interventional study of Placebo and MYK-461 in Healthy, sponsored by MyoKardia, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by MyoKardia, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, single ascending (oral) dose study in healthy volunteers aged 18-55 years.
Exclusion Criteria:
single-dose, tablet formulation
Drug: MYK-461
single-dose, tablet formulation
Drug: Placebo
Safety: Incidence of adverse events
Time frame: 28 Days
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
Time frame: 28 Days
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
Time frame: 28 Days
Determination of pharmacokinetics parameters
area under the concentrationtime curve (AUC)
Time frame: 28 Days
Determination of pharmacokinetics parameters
half-life (t1/2)
Time frame: 28 Days
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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MyoKardia, Inc.