Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects
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
- The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets
研究概览
简要总结
The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.
Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 tablet fasted
Single dose of GLPG0634 as tablets in fasted condition
干预措施: 200 mg GLPG0634 as tablets, fasted (Drug)
GLPG0634 capsule fasted
Single dose of GLPG0634 as capsules in fasted condition
干预措施: 200 mg GLPG0634 as capsules, fasted (Drug)
GLPG0634 tablet fed
Single dose of GLPG0634 as tablets in fed condition
干预措施: 200 mg GLPG0634 as tablets, fed (Drug)
结局指标
主要结局
The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets
时间窗: From predose (before first study drug administration) up to 144 hours post last study drug administration
To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.
次要结局
- The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets(Between screening and 7-10 days after the last dose)