A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107

Phase 1

Completed

• Conditions: Fragile X Syndrome
• Interventions: Drug: STX107

• Registration Number: NCT00965432
• Lead Sponsor: Seaside Therapeutics, Inc.

Brief Summary

The objectives of this study are to determine the safety and tolerability of single oral doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral doses of STX107 when administered via an oral suspension

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2009-09
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-05
• Last Update Posted: 2010-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Normal, healthy males 18-50 years old, inclusive.
• Able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	STX107	-
STX107	STX107	-

Primary Outcome Measures

Name	Time	Method
Adverse events	During the course of the study and for 14 days after completing the study

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States