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

NCT ID: NCT02366364

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drug: Placebo

Single oral administration on Day 1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single oral administration of placebo consumption on Day 1

Drug: NRX-1074 375 mg

Single oral administration on Day 1

Group Type: EXPERIMENTAL

NRX-1074 375 mg

Intervention Type: DRUG

Single oral administration of 375 mg consumption on Day 1

Drug: NRX-1074 500 mg

Single oral administration on Day 1

Group Type: EXPERIMENTAL

NRX-1074 500 mg

Intervention Type: DRUG

Single oral administration of 500 mg consumption on Day 1

Drug: NRX-1074 750 mg

Single oral administration on Day 1

Group Type: EXPERIMENTAL

NRX-1074 750 mg

Intervention Type: DRUG

Single oral administration of 750 mg consumption on Day 1

Interventions

Placebo

Single oral administration of placebo consumption on Day 1

Intervention Type: DRUG

NRX-1074 375 mg

Single oral administration of 375 mg consumption on Day 1

Intervention Type: DRUG

NRX-1074 500 mg

Single oral administration of 500 mg consumption on Day 1

Intervention Type: DRUG

NRX-1074 750 mg

Single oral administration of 750 mg consumption on Day 1

Intervention Type: DRUG

Other Intervention Names

NRX-1074 single oral dose; NRX-1074 single oral dose; NRX-1074 single oral dose

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Naurex, Inc, an affiliate of Allergan plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mimi Van Der Leden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chicago Research Center, Inc.

Locations

Chicago Research Center, Inc.

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NRX1074-C-102

Identifier Type: -

Identifier Source: org_study_id