A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam 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
- 24
- 试验地点
- 1
- 主要终点
- The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
研究概览
简要总结
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).
Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.
A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
干预措施: Midazolam (Drug)
Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
干预措施: Midazolam (Drug)
Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
干预措施: GLPG1837 500 mg (Drug)
Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
干预措施: GLPG1837 1000 mg (Drug)
结局指标
主要结局
The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
时间窗: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
时间窗: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
时间窗: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
时间窗: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
次要结局
- The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)(Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12))
- Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature(Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12)
- The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)(Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12))
- The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)(Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12))
- Changes in 12-lead ECG measures(Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12)
- Changes in physical exam measures(Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12)
- Number of adverse events(Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12)
- Changes in blood safety lab parameters(Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12)
- The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)(Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12))
- The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)(Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12))
- Changes in urine safety lab parameters(Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12)