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

Fragile X Syndrome Clinical Trial

Official title:

A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965432
• Other study ID #: 22006
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2009
• Last updated: February 5, 2010
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Seaside Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fragile X Syndrome

Intervention

Drug:
• STX107
Single dose of an oral suspension

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Seaside Therapeutics, Inc.	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		During the course of the study and for 14 days after completing the study	Yes