Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 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
- 45
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
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 GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 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
- •body mass index (BMI) between 18-30 kg/m², inclusive.
排除标准
- •significantly abnormal platelet function or coagulopathy
- •drug or alcohol abuse
- •hypersensitivity to any of the test substances
研究组 & 干预措施
GLPG0778 ascending doses
Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.
干预措施: GLPG0778 (Drug)
Placebo
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
Occurrence of adverse events
时间窗: Daily during treatment, up to 10 days postdose
At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
Evaluation of hematological, biochemical and cardiovascular parameters.
时间窗: until 10 days postdose.
On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
次要结局
- Pharmacokinetics of repeated doses(24 hours postdose)
- Pharmacodynamics (PD) of GLPG0778(up to 10 days postdose)