NCT01856556

Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	NRX-1074	Single IV or PO administration
DRUG	Placebo	Single IV or PO placebo administration

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-05-17
• Last updated: 2016-01-26

Locations

1 site across 1 country: United States