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OpenTrials
Completed

NCT Number: NCT01014650

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lotus Clinical Research

Pasadena, California, 91105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLYX-13

Drug

single IV or SC dose

Other names: NMDA receptor glycine site partial agonist

IV normal saline

Drug

Single IV dose of normal saline

Other names: Saline

Primary outcomes

  1. Observed and laboratory-confirmed safety

    Time frame: four weeks

Secondary outcomes

  1. 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.

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Naurex, Inc, an affiliate of Allergan plc

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2009
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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