Fragile X Syndrome
Conditions
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.
Interventions
DRUGSTX107
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
Sponsors
Seaside Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events will be monitored for tolerability | 1 day | physical exam, laboratories, collection of adverse events |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of STX107 will be measured to define pharmacokinetics | 1 day |
Countries
United States
Outcome results
None listed