NCT03445338已完成1 期
A Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- minimum concentration of study drug cerebrospinal fluid (CSF)
研究概览
简要总结
This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of K0706 in healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Healthy adult male subjects, 18 to 45 years of age, inclusive, at screening.
- •Willing and able to give written, and dated an informed consent.
- •Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions in the Investigator's opinion, and be accessible for follow-up.
- •Medically healthy on the basis of medical history and physical examination.
- •Subjects enrolled in the study should not father a child and follow the necessary precautionary measure to be taken during the course of the study.
排除标准
- •Subjects with a history of a frequent headache, nausea, or vomiting suggestive of increased intracranial pressure.
- •Subject report of recent (6-month) alcohol abuse or illicit drug use or who tests positive at screening, Check-in, or outpatient Visits for breath alcohol and/or drugs of abuse or cotinine;
- •Subjects with a history of any relevant allergy/hypersensitivity.
- •Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results.
- •Subjects who have participated in CSF collection studies within 56 days prior to check-in.
- •Subjects who donated plasma within 14 days prior to the check-in visit.
研究组 & 干预措施
Cohort 1
Experimental
干预措施: K0706 (Drug)
Cohort 2
Experimental
干预措施: K0706 (Drug)
Cohort 3
Experimental
干预措施: K0706 (Drug)
结局指标
主要结局
minimum concentration of study drug cerebrospinal fluid (CSF)
时间窗: Day 8
次要结局
未报告次要终点
研究者
研究点 (1)
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