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Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers

2014-08-27 03:17:56 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an NMDA receptor glycine site functional partial agonist, in normal, healthy human volunteers.

Description

NMDA receptor glycine site partial agonists (GFPAs) have been demonstrated to be efficacious in animal models and/or in early human studies of several CNS diseases including neuropathic pain, major depressive disorder, schizophrenia, Alzheimer's disease, anxiety including posttraumatic stress syndrome, and cognition in Down's syndrome and autism and others, without the psychomimetic side effects of NMDA receptor channel blockers. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side effects in animals. The purpose of this study is to evaluate the safety and pharmacokinetics of GLYX-13 following a single IV dose.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Healthy

Intervention

GLYX-13, IV normal saline

Location

Lotus Clinical Research
Pasadena
California
United States
91105

Status

Recruiting

Source

Naurex, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:56-0400

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