Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01856556
- Run by
- Naurex, Inc, an affiliate of Allergan plc
- People needed
- 100
- Starts
- 2013-05-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-01-26
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
Where it is running
- Lotus Clinical Research — Pasadena, California, United States
Full record on ClinicalTrials.gov
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