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History of Changes for Study: NCT03109756
Single Dose Pharmacokinetic (PK) Study
Latest version (submitted November 29, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 10, 2017 None (earliest Version on record)
2 September 14, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 November 29, 2017 Recruitment Status and Study Status
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Study NCT03109756
Submitted Date:  April 10, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: OV101-16-001
Brief Title: Single Dose Pharmacokinetic (PK) Study
Official Title: A Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman Syndrome
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2017
Overall Status: Recruiting
Study Start: April 3, 2017
Primary Completion: December 2017 [Anticipated]
Study Completion: December 2017 [Anticipated]
First Submitted: April 6, 2017
First Submitted that
Met QC Criteria:
April 10, 2017
First Posted: April 12, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 10, 2017
Last Update Posted: April 12, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Ovid Therapeutics Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Angelman Syndrome
Fragile X Syndrome
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Single-dose 5 mg OV101 Drug: OV101
Single-dose 5 mg OV101
Other Names:
  • Gaboxadol
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Measurement of maximum plasma concentration achieved following a single dose of OV101
[ Time Frame: 10 hours ]

Maximum plasma concentration (Cmax)
2. 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)
3. Measurement of plasma half-life following a single dose of OV101
[ Time Frame: 10 hours ]

Plasma half-life (T1/2)
4. 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)
5. Measurement of clearance following a single dose of OV101
[ Time Frame: 10 hours ]

Total body clearance (CL)
6. 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)
Secondary Outcome Measures:
1. Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram (ECG)
[ Time Frame: 10 hours ]

Open or close this module Eligibility
Minimum Age: 13 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Jeannie Visootsak, MD
Telephone: +1 (646) 661-7661
Email: info@ovidrx.com
Locations: United States, Illinois
Ovid Therapeutics Investigative Site
[Recruiting]
Chicago, Illinois, United States, 60612
Contact:Contact: Berry-Kravis, MD, PhD
United States, Tennessee
Ovid Therapeutics Investigative Site
[Recruiting]
Nashville, Tennessee, United States, 37212
Contact:Contact: Sanders, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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