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

Seaside Therapeutics, Inc.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fragile X Syndrome

Interventions

STX107DRUG

Single dose of an oral suspension

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Adverse events

Time frame: During the course of the study and for 14 days after completing the study

Data from ClinicalTrials.gov

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