Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
January 25, 2016 updated by: Naurex, Inc, an affiliate of Allergan plc
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Lotus Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Saline
|
Single IV or PO placebo administration
|
|
Experimental: NRX-1074, 1 mg
1 mg IV
|
Single IV or PO administration
Other Names:
|
|
Experimental: NRX-1074, 5 mg
5 mg IV
|
Single IV or PO administration
Other Names:
|
|
Experimental: NRX-1074, 10 mg IV
10 mg
|
Single IV or PO administration
Other Names:
|
|
Experimental: NRX-1074, 50 mg IV
50 mg
|
Single IV or PO administration
Other Names:
|
|
Experimental: NRX-1074, 25 mg PO
25 mg
|
Single IV or PO administration
Other Names:
|
|
Experimental: NRX-1074, 125 mg PO
125 mg
|
Single IV or PO administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Observed and laboratory-confirmed safety
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Grace Ting, MD, Lotus Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
May 13, 2013
First Submitted That Met QC Criteria
May 16, 2013
First Posted (Estimate)
May 17, 2013
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 25, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRX1074-C-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.