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

NCT02366364 | Completed Phase 1

• 1 other identifier: NRX1074-C-102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

NRX-1074; NMDA Receptor Modulator; Major Depressive Disorder; Glycine Site Modulator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Plasma pharmacokinetics Cmax

  For 24 hours after drug dose on Day 1

• Plasma pharmacokinetics - Tmax

  For 24 hours after drug dose on Day 7

Study Arms (4)

Drug: Placebo

PLACEBO COMPARATOR

Single oral administration on Day 1

Drug: Placebo

Drug: NRX-1074 375 mg

EXPERIMENTAL

Single oral administration on Day 1

Drug: NRX-1074 375 mg

Drug: NRX-1074 500 mg

EXPERIMENTAL

Single oral administration on Day 1

Drug: NRX-1074 500 mg

Drug: NRX-1074 750 mg

EXPERIMENTAL

Single oral administration on Day 1

Drug: NRX-1074 750 mg

Interventions

Placebo DRUG

Single oral administration of placebo consumption on Day 1

Drug: Placebo

NRX-1074 375 mg DRUG

Single oral administration of 375 mg consumption on Day 1

Also known as: NRX-1074 single oral dose

Drug: NRX-1074 375 mg

NRX-1074 500 mg DRUG

Single oral administration of 500 mg consumption on Day 1

Also known as: NRX-1074 single oral dose

Drug: NRX-1074 500 mg

NRX-1074 750 mg DRUG

Single oral administration of 750 mg consumption on Day 1

Also known as: NRX-1074 single oral dose

Drug: NRX-1074 750 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naurex, Inc, an affiliate of Allergan plc: lead

Study Sites (1)

Chicago Research Center, Inc.

Chicago, Illinois, 60634, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Mimi Van Der Leden, MD, PhD

  Chicago Research Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

US (1)