Trials / Suspended
SuspendedNCT01325740
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome
- Status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Seaside Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | STX107 | STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2011-03-30
- Last updated
- 2012-12-20
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01325740. Inclusion in this directory is not an endorsement.