Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)
研究概览
简要总结
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects be 18 years of age and 55 years of age and with a BMI >18.5 kg/m2 and <30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.
- •Other pre-defined inclusion and exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Lu AF1167 capsule 0.5 mg
Single oral dose (day 1)
干预措施: Lu AF11167 (Drug)
Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule
Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8
干预措施: Lu AF11167 (Drug)
Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule
Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)
时间窗: Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF11167
时间窗: Day 1 and 8
次要结局
- Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)(Day 1 and 8)
- Maximum observed plasma concentration (Cmax) of Lu AF36201(Day 1 and 8)