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Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers (NRX-1074)

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ClinicalTrials.gov Identifier: NCT02366364
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Brief Summary:
The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: NRX-1074 375 mg Drug: NRX-1074 500 mg Drug: NRX-1074 750 mg Phase 1

Detailed Description:
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses 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, psychotomimetic findings and subject-reported symptoms.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Drug: Placebo
Single oral administration on Day 1
Drug: Placebo
Single oral administration of placebo consumption on Day 1

Experimental: Drug: NRX-1074 375 mg
Single oral administration on Day 1
Drug: NRX-1074 375 mg
Single oral administration of 375 mg consumption on Day 1
Other Name: NRX-1074 single oral dose

Experimental: Drug: NRX-1074 500 mg
Single oral administration on Day 1
Drug: NRX-1074 500 mg
Single oral administration of 500 mg consumption on Day 1
Other Name: NRX-1074 single oral dose

Experimental: Drug: NRX-1074 750 mg
Single oral administration on Day 1
Drug: NRX-1074 750 mg
Single oral administration of 750 mg consumption on Day 1
Other Name: NRX-1074 single oral dose




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 28 days following study drug dose ]
    Observed side effects and changes in laboratory values


Secondary Outcome Measures :
  1. Plasma pharmacokinetics Cmax [ Time Frame: For 24 hours after drug dose on Day 1 ]
    Cmax after administration

  2. Plasma pharmacokinetics - Tmax [ Time Frame: For 24 hours after drug dose on Day 7 ]
    Tmax after administration



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
  • Clinical laboratory values <2 times 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:

  • Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing infectious disease.
  • Current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.
  • Current abuse of illicit substances, using the Diagnostic and Statistical Manual (DSM) IV definition of drug abuse.
  • Current smoker or use of other tobacco products.
  • Currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
  • Type I or Type II diabetes.
  • Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
  • Currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
  • History of allergy, sensitivity, or intolerance to NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.
  • Received another investigational drug or device within 30 days of enrollment in this study.
  • Previously participated in this study.
  • Psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug safety. 13) In the option of the Investigator or the Sponsor's Study Monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366364


Locations
United States, Illinois
Chicago Research Center, Inc.
Chicago, Illinois, United States, 60634
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
Principal Investigator: Mimi Van Der Leden, MD, PhD Chicago Research Center, Inc.

Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02366364     History of Changes
Other Study ID Numbers: NRX1074-C-102
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
NRX-1074
NMDA Receptor Modulator
Major Depressive Disorder
Glycine Site Modulator

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms