The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Cypress, California, United States
Unnamed facility
Stanford, California, United States
Unnamed facility
Boston, Massachusetts, United States
Safety: Incidence of adverse events
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by Cmax
maximum concentration (Cmax)
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by Tmax
time of the maximum measured concentration (Tmax)
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by AUC
area under the concentration-time curve (AUC)
Time frame: 28 Days
Determination of pharmacokinetics parameters as measured by t1/2
half-life (t1/2)
Time frame: 28 Days
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Unnamed facility
Kalamazoo, Michigan, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Nashville, Tennessee, United States