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Single Dose Pharmacokinetic (PK) Study

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ClinicalTrials.gov Identifier: NCT03109756
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Ovid Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date November 30, 2017
Actual Study Start Date  ICMJE April 3, 2017
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Pharmacokinetic (PK) Study
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Angelman Syndrome
  • Fragile X Syndrome
Intervention  ICMJE Drug: OV101
Single-dose 5 mg OV101
Other Name: Gaboxadol
Study Arms  ICMJE Experimental: Single-dose 5 mg OV101
Intervention: Drug: OV101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 28, 2017
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adolescents with confirmed clinical and previous molecular diagnosis of FXS or AS, age between 13 to 17 years, inclusive.
  2. Subjects must assent to participation in the study (if appropriate), have a parent or legal guardian/representative capable of providing informed consent on behalf of the subject, and commit to participate in all assessments described in the protocol.
  3. Subjects must be receiving a stable dose of concomitant medications
  4. Subjects should be able to complete study assessments.
  5. Subjects who are non-sterile must agree to either remain completely abstinent or to use two effective contraceptive methods from screening until 7 days after the last dose of study treatment.
  6. Subjects must have a parent or other reliable caregiver who agrees to accompany the subject at all study visits and provide information about the subject as required by the study protocol, and ensure compliance with the protocol.

Exclusion Criteria:

  1. Inability to swallow a capsule.
  2. Poorly controlled seizures
  3. Clinically significant abnormal ECG at the time of screening.
  4. Positive result on serum or urine pregnancy test for women of child-bearing potential (have experienced menarche) who are not using a dual method of contraception (e.g., condoms plus oral contraceptives), with abstinence being an accepted method.
  5. Allergy to gaboxadol or any excipients
  6. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study
  7. History of suicidal behavior or considered a high suicidal risk by the investigator.
  8. Any medical, psychological, social disorder(s), or other conditions - including seizure disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109756
Other Study ID Numbers  ICMJE OV101-16-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ovid Therapeutics Inc.
Study Sponsor  ICMJE Ovid Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ovid Therapeutics Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP