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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 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 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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
GLYX-13, IV normal saline
Lotus Clinical Research
Published on BioPortfolio: 2014-08-27T03:17:56-0400
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Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
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Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
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Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...