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

Seaside Therapeutics

Status and phase: Completed; Phase 1

Conditions: Fragile X Syndrome

Treatments: Drug: STX107

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00965432

22006

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: STX107

STX107

Active Comparator group

Treatment:

Drug: STX107