NCT00903253已完成1 期
A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasma Pharmacokinetics
研究概览
简要总结
The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754 as well as safety and tolerability in normal healthy male and female elderly volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females aged 60 to 75 years
- •Good general health as determined by medical history and physical examination
- •Body Mass Index of 18-32, inclusive
- •Estimate of creatinine clearance by Cockcroft-Gault that is normal for age and sex (greater than or equal to 60mL/min)
- •Normal hemoccult test at screening and baseline
- •Voluntarily consent to participate in the study
- •Willing to adhere to the protocol requirements
排除标准
- •Subjects with clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurological, sleep disorders by DSM-IV criteria, endocrine, hematological, or metabolic disease as determined by medical history and physical examination
- •Subjects who have been diagnosed with or meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV_TR) criteria for any significant psychiatric or psychoactive substance use disorder within the past year
- •Subjects with positive urine drug screen or compounds associated with abuse in the absence of medical justification for their presence
- •QTcB greater than 450 msec (males), or greater than 470 (females), based on the average interval of triplicate ECGs obtained after five minutes rest in a supine position using hte ECG algorithm
- •Clinically significant abnormal screening results or laboratory tests
- •Pregnant or nursing or planning a pregnancy, or planning on fathering a child
结局指标
主要结局
Plasma Pharmacokinetics
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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