A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Drug: Placebo
Single oral administration on Day 1
干预措施: Placebo (Drug)
Drug: NRX-1074 375 mg
Single oral administration on Day 1
干预措施: NRX-1074 375 mg (Drug)
Drug: NRX-1074 500 mg
Single oral administration on Day 1
干预措施: NRX-1074 500 mg (Drug)
Drug: NRX-1074 750 mg
Single oral administration on Day 1
干预措施: NRX-1074 750 mg (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 28 days following study drug dose
Observed side effects and changes in laboratory values
次要结局
- Plasma pharmacokinetics - Tmax(For 24 hours after drug dose on Day 7)
- Plasma pharmacokinetics Cmax(For 24 hours after drug dose on Day 1)