A Study to Assess the Tolerability of a Single Dose of ST... | NCT01325740

Studies
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome

NCT01325740

Sponsor

Seaside Therapeutics, Inc.

Status

Suspended

Last Update Posted

Dec 20, 2012Estimated

Enrollment

16Estimated

Phase

Phase 2

Conditions

Fragile X Syndrome

Interventions

STX107

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

pending further evaluation

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Mar 28, 2011

First Posted Date

Mar 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2012

Last Update Posted Date

Dec 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
STX107 10 mg	Active Comparator	Drug: STX107
Placebo	Placebo Comparator	Drug: STX107
STX107 30 mg	Active Comparator	Drug: STX107

Interventions

Name	Type	Description	Arm Group Labels	Other Names
STX107	Drug	STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule	Placebo STX107 10 mg STX107 30 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events will be monitored for tolerability	physical exam, laboratories, collection of adverse events	1 day

Secondary Outcomes

Measure	Description	Time Frame
Blood levels of STX107 will be measured to define pharmacokinetics		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male subjects 18 to 50 years of age, inclusive.
Molecular documentation of the full fragile X mutation.

Exclusion Criteria:

Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
Subjects who, in the Investigator's opinion, might not be suitable for the study

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California-Los Angeles Neuropsychiatric Institute		Los Angeles	California	90024	United States

Condition Browse Module

MeSH Terms

ID	Term
D005600	Fragile X Syndrome

Ancestor Terms

ID	Term
D038901	X-Linked Intellectual Disability
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided