NCT01361646已完成1 期
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Adverse events of LC350189
研究概览
简要总结
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 20 and 50 years at screening
- •Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
- •Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
排除标准
- 未提供
研究组 & 干预措施
LC350189
Experimental
干预措施: LC350189 (Drug)
Febuxostat
Active Comparator
干预措施: LC350189 (Drug)
Placebo
Placebo Comparator
干预措施: LC350189 (Drug)
结局指标
主要结局
Adverse events of LC350189
时间窗: 7 days(plus or minus 1 day)
次要结局
- Tmax(3days)
- Cmax(3 days)
- AUC(3days)
研究者
研究点 (1)
Loading locations...
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