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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Oral suspension
Nucleus Network
Melbourne, Victoria, Australia
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
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
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