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The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses 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, psychotomimetic findings and subject-reported symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Placebo | Placebo Comparator | Single oral administration on Day 1 |
|
| Drug: NRX-1074 375 mg | Experimental | Single oral administration on Day 1 |
|
| Drug: NRX-1074 500 mg | Experimental | Single oral administration on Day 1 |
|
| Drug: NRX-1074 750 mg | Experimental | Single oral administration on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single oral administration of placebo consumption on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Observed side effects and changes in laboratory values | 28 days following study drug dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics Cmax | Cmax after administration | For 24 hours after drug dose on Day 1 |
| Plasma pharmacokinetics - Tmax | Tmax after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mimi Van Der Leden, MD, PhD | Chicago Research Center, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Research Center, Inc. | Chicago | Illinois | 60634 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| NRX-1074 375 mg |
| Drug |
Single oral administration of 375 mg consumption on Day 1 |
|
|
| NRX-1074 500 mg | Drug | Single oral administration of 500 mg consumption on Day 1 |
|
|
| NRX-1074 750 mg | Drug | Single oral administration of 750 mg consumption on Day 1 |
|
|
| For 24 hours after drug dose on Day 7 |