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| ID | Type | Description | Link |
|---|---|---|---|
| 3R44NS071657-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Pharmaron | INDUSTRY |
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This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with stroke, subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of 5 once daily doses of NP10679 when delivered intravenously in three escalating dose levels in comparison to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo intravenous infusion over 30 minutes, five days of once daily dosing |
|
| NP10679 25 mg | Experimental | NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing |
|
| NP10679 50 mg | Experimental | NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing |
|
| NP10679 100 mg | Experimental | NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo via 30 minute infusion once daily for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events as a measure of safety and tolerability | Observed side effects and alteration in laboratory values | 10 days |
| Plasma concentration of parent drug | Pharmacokinetic parameters during dosing period through 4 days post dosing | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36642931 | Derived | Zaczek R, Traynelis SF, Dingledine R, Koszalka GW, Laskowitz DT. Phase 1 Clinical Results for NP10679, a pH-sensitive GluN2B-selective N-methyl-d-aspartate Receptor Inhibitor. Clin Pharmacol Drug Dev. 2023 Jul;12(7):706-717. doi: 10.1002/cpdd.1217. Epub 2023 Jan 15. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D010149 | Pain, Postoperative |
| D019966 | Substance-Related Disorders |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| NP10679 |
| Drug |
NP10679 25 mg via 30 minute infusion once daily for 5 days |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |