Status:
COMPLETED
A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
Lead Sponsor:
Seaside Therapeutics, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Fragile X Syndrome
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 wh...
Eligibility Criteria
Inclusion
- Normal, healthy males 18-50 years old, inclusive.
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00965432
Start Date
September 1 2009
End Date
February 1 2010
Last Update
February 8 2010
Active Locations (1)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704