drugset
drugset / Trial / NCT01856556

Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

NCT01856556 ↗

Phase 1 Completed 100 enrolled Naurex, Inc
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2013-05
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Apimostinel Protein / enzyme biologic 1 mg Intravenous
Subject Apimostinel Protein / enzyme biologic 5 mg Intravenous
Subject Apimostinel Protein / enzyme biologic 10 mg Intravenous
Subject Apimostinel Protein / enzyme biologic 25 mg Intravenous
Subject Apimostinel Protein / enzyme biologic 50 mg Intravenous
Subject Apimostinel Protein / enzyme biologic 125 mg Intravenous

Indications

No indication recorded.