临床试验/NCT01023321

NCT01023321已完成1 期

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Galapagos NV1 个研究点分布在 1 个国家目标入组 35 人开始时间: 2009年12月最近更新: 2010年8月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Galapagos NV
入组人数: 35
试验地点: 1
主要终点: Safety and tolerability of single and multiple dosing

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 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: GLPG0555 (Drug)

2

Placebo Comparator

single dose placebo

干预措施: placebo (Drug)

3

Experimental

multiple dose, 7 or 14 days, oral solution

干预措施: GLPG0555 (Drug)

4

Placebo Comparator

multiple dose, 7 or 14 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

Pharmacokinetics of single and repeated doses, including effect of food.(up to 10 days postdose)
To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration(up to 72 hours postdose)

研究者

发起方

Galapagos NV

申办方类型

Industry

研究点 (1)

Loading locations...

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