Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 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
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability of multiple dosing
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 (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.
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
Aqueous formulations for formulation selection
50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation
干预措施: GLPG0555 (Drug)
GLPG0555 ascending doses
multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily)
干预措施: GLPG0555 aqueous (Drug)
3
once or twice daily for 13 days, matching the scheme of the multiple ascending dose.
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability of multiple dosing
时间窗: Daily during treatment, up to 10 days postdose
次要结局
- Pharmacokinetics of repeated doses(24 hours postdose)
- Pharmacodynamics (PD) of GLPG0555 after repeated oral administration(up to 10 days postdose)
- The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days(up to 24 hours postdose)