Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Single Intravenous and Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: NRX-1074
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects Aged 18 to 55 years For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drugIf of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NRX-1074, 1 mg<br>1 mg IV | Drug: NRX-1074<br>* Single IV or PO administration<br>* Other names: NMDA receptor functional glycine-site partial agonist;|
| Placebo Comparator: Placebo<br>Saline | Drug: Placebo<br>* Single IV or PO placebo administration<br>|
| Experimental: NRX-1074, 5 mg<br>5 mg IV | Drug: NRX-1074<br>* Single IV or PO administration<br>* Other names: NMDA receptor functional glycine-site partial agonist;|
| Experimental: NRX-1074, 10 mg IV<br>10 mg | Drug: NRX-1074<br>* Single IV or PO administration<br>* Other names: NMDA receptor functional glycine-site partial agonist;|
| Experimental: NRX-1074, 50 mg IV<br>50 mg | Drug: NRX-1074<br>* Single IV or PO administration<br>* Other names: NMDA receptor functional glycine-site partial agonist;|
| Experimental: NRX-1074, 25 mg PO<br>25 mg | Drug: NRX-1074<br>* Single IV or PO administration<br>* Other names: NMDA receptor functional glycine-site partial agonist;|
| Experimental: NRX-1074, 125 mg PO<br>125 mg | Drug: NRX-1074<br>* Single IV or PO administration<br>* Other names: NMDA receptor functional glycine-site partial agonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed and laboratory-confirmed safety |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, tolerability, pharmacokinetics