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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00965432
• Date of registration: 24/08/2009
• Prospective Registration: Yes
• Primary sponsor: Seaside Therapeutics, Inc.
• Public title: A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00965432
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: STX107

Primary Outcome(s)

Adverse events [Time Frame: During the course of the study and for 14 days after completing the study]

Secondary ID(s)

22006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)