NCT05921929撤回1 期
Safety and Pharmacokinetics of a Novel NMDA Receptor Antagonist Against Brain Related Diseases in Healthy Adult Volunteers: First-in-human, Phase I, Single Dose-escalating, Open Label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are:
- What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)?
- What is the PK profile of single ascending doses of the FENM in human?
- What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •willing and able to sign written informed consent,
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, a total body weight >65 kg,
- •efficient contraceptive mean,
- •no major psychiatric disorder per the Mini-International Neuropsychiatric Interview (MINI) questionnaire,
- •normal laboratory tests results, arterial Blood Pressure/pulse rate, 12-lead Electrocardiogram recording.
排除标准
- •evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease including drug allergies, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality,
- •history of febrile illness within 5 days prior to administration,
- •any condition possibly affecting drug absorption,
- •using of prescription drugs, vaccine, routine or as needed consumption of medications or herbal supplements,
- •having positive serology, positive urine test for drugs of abuse, a general medical or psychological condition or behavior, including current substance dependence or abuse,
- •history of drug or alcohol abuse within 1 year before screening,
- •consuming currently of nicotine containing products, any food or any beverage containing grapefruit or grapefruit juice within 48 h prior to administration,
- •having blood donation or loss of significant amount of blood within 2 months prior to study.
研究组 & 干预措施
One single oral dose per participant
Experimental
干预措施: Fluoroethylnormemantine (FENM) (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: From single dose administration to the end of the study follow-up (2 weeks later)
次要结局
- To assess preliminary exploratory time course of Brain Disease Neurotrophic Factor plasmatic levels of single ascending doses of the FENM(At pre-dose, at Cmax (estimated at 6-8hours post-dose) and at 48, 72 and 264hours post-dose)
- To assess time to Cmax [Tmax](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess last observed plasma concentration [Clast](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess area under the plasma concentration-time curve from dosing (time 0) to the time of last measured concentration [AUC 0-last](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess minimum concentration within the dosing interval [Cmin](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess area under the plasma concentration-time curve from 0 to the end of the dose interval [AUC 0-tau](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess total area under the plasma concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large (infinity) [AUC 0-∞](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess time of the minimum concentration [Tmax](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess apparent volume of distribution [Vz/F](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess terminal half-life, apparent elimination half-life [T1/2](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess apparent oral clearance [CL/F](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
- To assess maximum plasma concentration [Cmax](At pre-dose and at 2, 4, 6, 8, 10, 12, 24, 48, 96, 189, 264 and 336hours post-dose)
研究者
研究点 (1)
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