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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional partial agonist, in normal, healthy human volunteers.

Detailed Description
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NMDA receptor glycine site partial agonists (GFPAs) have been demonstrated to be efficacious in animal models and/or in early human studies of several Central Nervous System (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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Single Intravenous Dose, Ascending Dose Level Study of the Safety, Tolerability and Pharmacokinetics of GLYX-13 in Normal Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLYX-13
* Drug: IV normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical laboratory values < 2x the upper limit of normal ability to understand the requirements of the study and provide informed consent Exclusion Criteria: alcohol abuse abuse of illicit substances current smoker currently taking prescription medications (other than for birth control) history of allergy to NMDA receptor ligands received another investigational drug within 30 days psychiatric disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: IV normal saline<br>Single IV dose of normal saline as a control for safety and tolerability observations | Drug: IV normal saline<br>* Single IV dose of normal saline<br>* Other names: Saline;|
| Experimental: IV GLYX-13<br>Single IV dose of GLYX-13 | Drug: GLYX-13<br>* single IV or SC dose<br>* Other names: NMDA receptor glycine site partial agonist;|
| Experimental: SC GLYX-13<br>Single SC dose | Drug: GLYX-13<br>* single IV or SC dose<br>* Other names: NMDA receptor glycine site partial agonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed and laboratory-confirmed safety |  | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycine site partial agonist, normal volunteers, safety in normal volunteers