NCT01278095已完成1 期
A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation
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
- 12
- 试验地点
- 1
- 主要终点
- Bioavailability of solid formulation
研究概览
简要总结
The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •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
GLPG0555 solid dispersion, fed
Experimental
50 mg as solid dispersion capsule, after breakfast
干预措施: GLPG0555 solid dispersion (Drug)
GLPG0555 solid dispersion, fasting
Experimental
50 mg as solid dispersion capsule, in fasting condition
干预措施: GLPG0555 solid dispersion (Drug)
GLPG0555 nanosuspension, fed
Experimental
50 mg as nanosuspension, given after breakfast
干预措施: GLPG0555 nanosuspension (Drug)
结局指标
主要结局
Bioavailability of solid formulation
时间窗: 72 hrs
次要结局
- Safety and tolerability of single doses of GLPG0555(up to 10 days postdose)
研究者
研究点 (1)
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