NCT00905138已完成1 期
Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects
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
- Galapagos NV
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single and multiple dosing
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male, age 18-50 years
- •BMI between 18-30 kg/m², inclusive.
排除标准
- •significantly abnormal platelet function or coagulopathy
- •drug or alcohol abuse
研究组 & 干预措施
1
Experimental
single ascending doses
干预措施: GLPG0259 (Drug)
2
Placebo Comparator
single dose placebo
干预措施: placebo (Drug)
3
Experimental
multiple dose, 5 days, oral solution
干预措施: GLPG0259 (Drug)
4
Placebo Comparator
multiple dose, 5 days, oral solution
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability of single and multiple dosing
时间窗: up to 10 days postdose
次要结局
- Exploratory evaluation of TNF-alpha and IL6 in whole blood(up to 12 hours postdose)
- Pharmacokinetics of single and repeated doses(up to 10 days postdose)
研究者
研究点 (1)
Loading locations...
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