Clinical Trial: Single Dose Pharmacokinetic (PK) Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman Syndrome

Brief Summary:

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.

Detailed Summary:
Sponsor: Ovid Therapeutics Inc.

Current Primary Outcome:

  • Measurement of maximum plasma concentration achieved following a single dose of OV101 [ Time Frame: 10 hours ]
    Maximum plasma concentration (Cmax)
  • Measurement of time of maximum plasma concentration following a single dose of OV101 [ Time Frame: 10 hours ]
    Time after administration of drug when maximum plasma concentration is reached (Tmax)
  • Measurement of plasma half-life following a single dose of OV101 [ Time Frame: 10 hours ]
    Plasma half-life (T1/2)
  • Measurement of the area under the plasma concentration versus time curve following a single dose of OV101 [ Time Frame: 10 hours ]
    Area under the curve from 0 to 10 hours (AUC 0-10)
  • Measurement of clearance following a single dose of OV101 [ Time Frame: 10 hours ]
    Total body clearance (CL)
  • Measurement of the apparent volume of distribution following a single dose of OV101 [ Time Frame: 10 hours ]
    Apparent volume of distribution during terminal phase (Vz)


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram (ECG) [ Time Frame: 10 hours ]

Original Secondary Outcome: Same as current

Information By: Ovid Therapeutics Inc.

Dates:
Date Received: April 6, 2017
Date Started: April 3, 2017
Date Completion: December 2017
Last Updated: April 10, 2017
Last Verified: April 2017