drugset / Trial / NCT03109756

Single Dose Pharmacokinetic (PK) Study

NCT03109756

Phase 1 Completed 12 enrolled Healx AI
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

EvaluationDrugModalityDoseRoute
Subject gaboxadol Small molecule 5 mg