The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome (FXS) or Angelman syndrome (AS). * The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101 following a single 5 mg dose of OV101 in adolescents with FXS or AS. * Secondary objectives are to determine the safety and tolerability of a single 5 mg dose of OV101 in adolescents with FXS or AS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single-dose 5 mg OV101
Ovid Therapeutics Investigative Site
Chicago, Illinois, United States
Ovid Therapeutics Investigative Site
Nashville, Tennessee, United States
Measurement of maximum plasma concentration achieved following a single dose of OV101
Maximum plasma concentration (Cmax)
Time frame: 10 hours
Measurement of time of maximum plasma concentration following a single dose of OV101
Time after administration of drug when maximum plasma concentration is reached (Tmax)
Time frame: 10 hours
Measurement of plasma half-life following a single dose of OV101
Plasma half-life (T1/2)
Time frame: 10 hours
Measurement of the area under the plasma concentration versus time curve following a single dose of OV101
Area under the curve from 0 to 10 hours (AUC 0-10)
Time frame: 10 hours
Measurement of clearance following a single dose of OV101
Total body clearance (CL)
Time frame: 10 hours
Measurement of the apparent volume of distribution following a single dose of OV101
Apparent volume of distribution during terminal phase (Vz)
Time frame: 10 hours
Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram (ECG)
Time frame: 10 hours
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