A Randomized, Double-Blind, Placebo-Controlled Single Intravenous Dose, Ascending Dose Level Study of the Safety, Tolerability and Pharmacokinetics of GLYX-13 in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Observed and laboratory-confirmed safety
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional partial agonist, in normal, healthy human volunteers.
详细描述
NMDA receptor glycine site partial agonists (GFPAs) have been demonstrated to be efficacious in animal models and/or in early human studies of several Central Nervous System (CNS) diseases including neuropathic pain, major depressive disorder, schizophrenia, Alzheimer's disease, anxiety including posttraumatic stress syndrome, and cognition in Down's syndrome and autism and others, without the psychomimetic side effects of NMDA receptor channel blockers. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side effects in animals. The purpose of this study is to evaluate the safety and pharmacokinetics of GLYX-13 following a single IV dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •clinical laboratory values < 2x the upper limit of normal
- •ability to understand the requirements of the study and provide informed consent
排除标准
- •alcohol abuse
- •abuse of illicit substances
- •current smoker
- •currently taking prescription medications (other than for birth control)
- •history of allergy to NMDA receptor ligands
- •received another investigational drug within 30 days
- •psychiatric disease
研究组 & 干预措施
IV normal saline
Single IV dose of normal saline as a control for safety and tolerability observations
干预措施: IV normal saline (Drug)
IV GLYX-13
Single IV dose of GLYX-13
干预措施: GLYX-13 (Drug)
SC GLYX-13
Single SC dose
干预措施: GLYX-13 (Drug)
结局指标
主要结局
Observed and laboratory-confirmed safety
时间窗: four weeks
次要结局
- Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects.(24 hours)