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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLYX-13 | Drug | single IV or SC dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observed and laboratory-confirmed safety | four weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research | Pasadena | California | 91105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25782764 | Derived | Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93. |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| IV normal saline | Drug | Single IV dose of normal saline |
|
|
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |