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The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings and subject-reported symptoms.
The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.
Randomized, double-blind, placebo-controlled, single ascending dose level study. On Day 1, eligibility of each subject will be confirmed, physical examination will be performed, and blood and urine for laboratories will be obtained. Each subject will be randomized, then will receive either a single IV, SC or IN dose of GLYX-13 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRX-1074, 1 mg | Experimental | 1 mg IV |
|
| Placebo | Placebo Comparator | Saline |
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| NRX-1074, 5 mg | Experimental | 5 mg IV |
|
| NRX-1074, 10 mg IV | Experimental | 10 mg |
|
| NRX-1074, 50 mg IV | Experimental | 50 mg |
|
| NRX-1074, 25 mg PO | Experimental | 25 mg |
|
| NRX-1074, 125 mg PO | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRX-1074 | Drug | Single IV or PO administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observed and laboratory-confirmed safety | 28 days |
| 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 |
|---|---|---|
| Grace Ting, MD | Lotus Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research | Pasadena | California | 91105 | United States |
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125 mg |
|
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| Placebo | Drug | Single IV or PO placebo administration |
|