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Trial record 2 of 3 for:    STX107

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

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ClinicalTrials.gov Identifier: NCT00965432
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : February 8, 2010
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
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

Condition or disease Intervention/treatment Phase
Fragile X Syndrome Drug: STX107 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: STX107
Single dose of an oral suspension
Active Comparator: STX107 Drug: STX107
Single dose of an oral suspension



Primary Outcome Measures :
  1. Adverse events [ Time Frame: During the course of the study and for 14 days after completing the study ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965432


Locations
United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Seaside Therapeutics, Inc.
National Institutes of Health (NIH)

Responsible Party: Randall Carpenter, President and CEO, Seaside Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT00965432     History of Changes
Other Study ID Numbers: 22006
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System