The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States
University of California-Davis, M.I.N.D. Institute
Sacramento, California, United States
University of Colorado Denver, Children's Hospital
Aurora, Colorado, United States
Emory University School of Medicine
Decatur, Georgia, United States
Adverse events will be monitored for tolerability
physical exam, laboratories, collection of adverse events
Time frame: 1 day
Blood levels of STX107 will be measured to define pharmacokinetics
Time frame: 1 day
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Rush University Medical Center
Chicago, Illinois, United States