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

Major Depressive Disorder Clinical Trial

— NRX-1074  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366364
• Other study ID #: NRX1074-C-102
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2015
• Last updated: February 18, 2016
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Naurex, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Single oral administration of placebo consumption on Day 1
• NRX-1074 375 mg
Single oral administration of 375 mg consumption on Day 1
• NRX-1074 500 mg
Single oral administration of 500 mg consumption on Day 1
• NRX-1074 750 mg
Single oral administration of 750 mg consumption on Day 1

Locations

Country	Name	City	State
United States	Chicago Research Center, Inc.	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Naurex, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Plasma pharmacokinetics Cmax	Cmax after administration	For 24 hours after drug dose on Day 1	No
Secondary	Plasma pharmacokinetics - Tmax	Tmax after administration	For 24 hours after drug dose on Day 7	No