NCT01419990已完成1 期
Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 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
- 16
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.
During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male, age 40-60 years
- •BMI between 18-30 kg/m2
排除标准
- •Any condition that might interfere with the procedures or tests in this study
- •Drug or alcohol abuse
研究组 & 干预措施
GLPG0634 capsules
Experimental
干预措施: GLPG0634 (Drug)
Placebo capsules
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: From screening up to 10 days after the last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
次要结局
- Pharmacokinetics (PK) and pharmacodynamics (PD)(From first dose up to 10 days after the last dose)
研究者
研究点 (1)
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