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

A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: NRX-1074 375 mg; Drug: NRX-1074 500 mg; Drug: NRX-1074 750 mg

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
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center, Inc.

Participation Criteria

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. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: NRX-1074 single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability	Observed side effects and changes in laboratory values	28 days following study drug dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma pharmacokinetics Cmax	Cmax after administration	For 24 hours after drug dose on Day 1
Plasma pharmacokinetics - Tmax	Tmax after administration	For 24 hours after drug dose on Day 7

Collaborators and Investigators

• Sponsor: Naurex, Inc, an affiliate of Allergan plc
• Investigators: Principal Investigator: Mimi Van Der Leden, MD, PhD, Chicago Research Center, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; NRX-1074; NMDA Receptor Modulator; Glycine Site Modulator
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NRX1074-C-102