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CompletedNCT01856556Updated Jan 26, 2016

Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

A Phase 1 interventional study of NRX-1074 and Placebo in Healthy, sponsored by Naurex, Inc, an affiliate of Allergan plc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-26.

Sponsored by Naurex, Inc, an affiliate of Allergan plc (part of AbbVie) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • safety
  • tolerability
  • pharmacokinetics
03

In context

Lead sponsor

Naurex, Inc, an affiliate of Allergan plc is the lead sponsor of 20 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

First submitted before Naurex, Inc became part of AbbVie.

Browse Naurex, Inc studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male and female subjects
  2. Aged 18 to 55 years
  3. 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.
  4. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
  5. 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

Exclusion Criteria:

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    NRX-1074, 1 mg

    1 mg IV

    Drug: NRX-1074

  • Placebo comparator
    Placebo

    Saline

    Drug: Placebo

  • Experimental
    NRX-1074, 5 mg

    5 mg IV

    Drug: NRX-1074

  • Experimental
    NRX-1074, 10 mg IV

    10 mg

    Drug: NRX-1074

  • Experimental
    NRX-1074, 50 mg IV

    50 mg

    Drug: NRX-1074

  • Experimental
    NRX-1074, 25 mg PO

    25 mg

    Drug: NRX-1074

  • Experimental
    NRX-1074, 125 mg PO

    125 mg

    Drug: NRX-1074

Interventions

  • DrugNRX-1074

    Single IV or PO administration

    Also known as: NMDA receptor functional glycine-site partial agonist

  • DrugPlacebo

    Single IV or PO placebo administration

06

What researchers measure

Primary outcomes

  1. Observed and laboratory-confirmed safety

    Time frame: 28 days

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Lotus Clinical Research
    Pasadena, California 91105, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2013
First posted
May 17, 2013
Start
May 2013
Primary completionActual
Nov 2014
CompletionActual
Nov 2014
Last update
Jan 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01856556
Lead sponsor
Naurex, Inc, an affiliate of Allergan plc
Responsible party
Sponsor
First posted
May 17, 2013
Start date
May 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Jan 26, 2016

Study contacts

Grace Ting, MD
principal investigator · Lotus Clinical Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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