Double-blind, Randomized, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0974 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
- 32
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.
Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.
Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
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
50 mg GLPG0974 or placebo
50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
干预措施: GLPG0974 (Drug)
50 mg GLPG0974 or placebo
50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
干预措施: Placebo (Drug)
100 mg GLPG0974 or placebo
100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
干预措施: GLPG0974 (Drug)
100 mg GLPG0974 or placebo
100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
干预措施: Placebo (Drug)
200 mg GLPG0974 or placebo
200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
干预措施: GLPG0974 (Drug)
200 mg GLPG0974 or placebo
200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
干预措施: Placebo (Drug)
400 mg GLPG0974 or placebo
400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
干预措施: GLPG0974 (Drug)
400 mg GLPG0974 or placebo
400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
次要结局
- The amount of GLPG0974 in plasma and urine over time after multiple oral dose(Between Day 1 predose and Day 14)
- Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974(Day 1 and Day 13, predose until 24h post dose)