Status:
COMPLETED
Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
Lead Sponsor:
Naurex, Inc, an affiliate of Allergan plc
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 adver...
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 fo...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01856556
Start Date
May 1 2013
End Date
November 1 2014
Last Update
January 26 2016
Active Locations (1)
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1
Lotus Clinical Research
Pasadena, California, United States, 91105