NCT03140813

An Initial Study of AZD7325 in Adults With Fragile X Syndrome

An Initial Double-Blind, Placebo-Controlled Two-Dose Crossover Study of AZD7325 in Adults With Fragile X Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety, tolerability and blood pharmacodynamics of treatment with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers during treatment.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	AZD7325 (High-Dose)	15mg PO BID
DRUG	AZD7325 (Low-Dose)	5mg PO BID
DRUG	Placebo oral capsule	Placebo will be dosed similar to AZD7325, in terms of dosage form, frequency and duration.

Timeline

• Start date: 2018-01-16
• Primary completion: 2020-06-18
• Completion: 2020-06-18
• First posted: 2017-05-04
• Last updated: 2021-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study