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Single Dose Pharmacokinetic (PK) Study

Descriptive Information
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
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
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Measurement of maximum plasma concentration achieved following a single dose of OV101
Secondary Outcome Measure † Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram (ECG)
Condition † Angelman Syndrome Fragile X Syndrome
Intervention † DrugOV101
Study Arms / Comparison Groups Single-dose 5 mg OV101
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 12
Start Date † April 3, 2017
Completion Date December 2017
Primary Completion Date December 2017
Eligibility 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
Gender All
Ages 13 Years - 17 Years
Accepts Healthy Volunteers No
Contacts †† Jeannie Visootsak, MD, +1 (646) 661-7661, info@ovidrx.com
Location Countries † United States
Administrative Information
NCT ID † NCT03109756
Organization ID OV101-16-001
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Ovid Therapeutics Inc.
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date April 2017
First Received Date † April 6, 2017
Last Updated Date April 10, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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