NCT02366364

Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Single oral administration of placebo consumption on Day 1
DRUG	NRX-1074 375 mg	Single oral administration of 375 mg consumption on Day 1
DRUG	NRX-1074 500 mg	Single oral administration of 500 mg consumption on Day 1
DRUG	NRX-1074 750 mg	Single oral administration of 750 mg consumption on Day 1

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-02-19
• Last updated: 2016-02-22

Locations

1 site across 1 country: United States