Double-blind Placebo-controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG0634 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 48
- 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 doses of GLPG0634 compared to placebo (with and without food).
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 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
- 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
- •body mass index (BMI) between 18-30 kg/m², inclusive.
排除标准
- •any condition that might interfere with the procedures or tests in the study
- •drug or alcohol abuse
研究组 & 干预措施
1
single ascending doses
干预措施: GLPG0634 (Drug)
2
single dose placebo
干预措施: placebo (Drug)
3
multiple dose, 10 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).
干预措施: GLPG0634 (Drug)
4
multiple dose, capsules, 10 days; scheme to match that of Study Arm 3.
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
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.
次要结局
- Pharmacokinetics of single and repeated doses, including effect of food.(up to 10 days postdose)