NCT03109756

Single Dose Pharmacokinetic (PK) Study

A Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Healx AI · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angelman Syndrome
• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	OV101	Single-dose 5 mg OV101

Timeline

• Start date: 2017-04-03
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2017-04-12
• Last updated: 2017-11-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study