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

This study has been completed.

First Received on August 24, 2009. Last Updated on February 5, 2010 History of Changes

Sponsor:	Seaside Therapeutics, Inc.
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00965432

Purpose

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	Intervention	Phase
Fragile X Syndrome	Drug: STX107	Phase I

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
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

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome fragile X syndrome MECP2 duplication syndrome PPM-X syndrome tetrasomy 18p

MedlinePlus related topics: Fragile X Syndrome

U.S. FDA Resources

Further study details as provided by Seaside Therapeutics, Inc.:

Primary Outcome Measures:

Adverse events [ Time Frame: During the course of the study and for 14 days after completing the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	September 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: STX107 Single dose of an oral suspension
Active Comparator: STX107	Drug: STX107 Single dose of an oral suspension

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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)

More Information

No publications provided

Responsible Party:	Randall Carpenter, President and CEO, Seaside Therapeutics, LLC
ClinicalTrials.gov Identifier:	NCT00965432 History of Changes
Other Study ID Numbers:	22006
Study First Received:	August 24, 2009
Last Updated:	February 5, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fragile X Syndrome
Mental Retardation, X-Linked
Mental Retardation
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

ClinicalTrials.gov processed this record on February 09, 2012