The Effect of Multiple Subcutaneous Doses of Risankizumab on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) Administered Orally in an Open-label, One-sequence Trial in Patients With Plaque Psoriasis With or Without Concomitant Psoriatic Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point
研究概览
简要总结
To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a means of predicting drug-drug interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
All patients
干预措施: Omeprazole (Drug)
All patients
干预措施: Metoprolol (Drug)
All patients
干预措施: Midazolam (Drug)
All patients
干预措施: Risankizumab (Drug)
All patients
干预措施: Caffeine (Drug)
All patients
干预措施: Warfarin (Drug)
结局指标
主要结局
AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 98-101
AUC0 - tz (area under the concentration-time curve) of caffeine without risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 1-3
Cmax (maximum measured concentration) of the analyte omeprazole without risankizumab in plasma
时间窗: Day 1
AUC0 - tz (area under the concentration-time curve) of warfarin without risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 1-8
AUC0 - tz (area under the concentration-time curve) of omeprazole with risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 98 - 100
AUC0 - tz (area under the concentration-time curve) of omeprazole without risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 1-2
Cmax (maximum measured concentration) of the analyte warfarin with risankizumab in plasma
时间窗: Day 98
Cmax (maximum measured concentration) of the analyte warfarin without risankizumab in plasma
时间窗: Day 1
AUC0 - tz (area under the concentration-time curve) of warfarin with risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 98 - 105
Cmax (maximum measured concentration) of the analyte omeprazole with risankizumab in plasma
时间窗: Day 98
AUC0 - tz (area under the concentration-time curve) of metoprolol with risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 98 -100
AUC0 - tz (area under the concentration-time curve) of metoprolol without risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 1-3
AUC0 - tz (area under the concentration-time curve) of midazolam with risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 98 - 99
Cmax (maximum measured concentration) of the analyte metoprolol with risankizumab in plasma
时间窗: Day 98
Cmax (maximum measured concentration) of the analyte metoprolol without risankizumab in plasma
时间窗: Day 1
Cmax (maximum measured concentration) of the analyte midazolam without risankizumab in plasma
时间窗: Day 1
Cmax (maximum measured concentration) of the analyte caffeine without risankizumab in plasma
时间窗: Day 1
AUC0 - tz (area under the concentration-time curve) of midazolam without risankizumab in plasma over time interval from 0 to last quantifiable data point
时间窗: Day 1-2
Cmax (maximum measured concentration) of the analyte midazolam with risankizumab in plasma
时间窗: Day 98
Cmax (maximum measured concentration) of the analyte caffeine with risankizumab in plasma
时间窗: Day 98
次要结局
未报告次要终点