A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Major Depressive Disorder
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events as a measure of safety and tolerability
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Drug: Placebo
Single oral administration on Day 1
Intervention: Placebo
Drug: NRX-1074 375 mg
Single oral administration on Day 1
Intervention: NRX-1074 375 mg
Drug: NRX-1074 500 mg
Single oral administration on Day 1
Intervention: NRX-1074 500 mg
Drug: NRX-1074 750 mg
Single oral administration on Day 1
Intervention: NRX-1074 750 mg
Outcomes
Primary Outcomes
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 Outcomes
- Plasma pharmacokinetics - Tmax(For 24 hours after drug dose on Day 7)
- Plasma pharmacokinetics Cmax(For 24 hours after drug dose on Day 1)