Trial | NCT01014650  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    53
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.
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.
Study Started
Nov 30
2009
Primary Completion
Oct 31
2015
Study Completion
Oct 31
2015
Last Update
Feb 22
2016
Estimate

Drug GLYX-13

single IV or SC dose

  • Other names: NMDA receptor glycine site partial agonist

Drug IV normal saline

Single IV dose of normal saline

  • Other names: Saline

IV normal saline Placebo Comparator

Single IV dose of normal saline as a control for safety and tolerability observations

IV GLYX-13 Experimental

Single IV dose of GLYX-13

SC GLYX-13 Experimental

Single SC dose

Criteria 

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
No Results Posted