drugset / Trial / NCT03109756
Single Dose Pharmacokinetic (PK) Study
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-04-03
- Primary completion
- 2017-11-28
- Completion
- 2017-11-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | gaboxadol | Small molecule | 5 mg | — |