NCT00928343已完成1 期
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 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
- 18
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single subcutaneous and oral 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) subcutaneous and single oral dose of GLPG0187 compared to placebo.
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and 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
- 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
GLPG0187
Experimental
Single dose
干预措施: GLPG0187 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single subcutaneous and oral dosing
时间窗: up to day 10 postdose
次要结局
- Pharmacokinetics of single subcutaneous and oral doses(up to 10 days postdose)
- Exploratory evaluation of S-CTX(up to 24 hrs postdose)
研究者
研究点 (1)
Loading locations...
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