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

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ClinicalTrials.gov Identifier: NCT01014650
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: GLYX-13 Drug: IV normal saline Phase 1

Detailed 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: IV normal saline
Single IV dose of normal saline as a control for safety and tolerability observations
 Drug: IV normal saline
Single IV dose of normal saline
Other Name: Saline
Experimental: IV GLYX-13
Single IV dose of GLYX-13
 Drug: GLYX-13
single IV or SC dose
Other Name: NMDA receptor glycine site partial agonist
Experimental: SC GLYX-13
Single SC dose
 Drug: GLYX-13
single IV or SC dose
Other Name: NMDA receptor glycine site partial agonist


Outcome Measures
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Primary Outcome Measures :
  1. Observed and laboratory-confirmed safety [ Time Frame: four weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014650


Locations
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United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Neil Singla, MD Lotus Clinical Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT01014650    
Other Study ID Numbers: GLYX13-C-101
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
glycine site partial agonist
normal volunteers
safety in normal volunteers
Additional relevant MeSH terms:
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Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs