NCT02342717已完成1 期
Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC0-167 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 167 h)
研究概览
简要总结
To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Reference
Experimental
single dose BI 425809
干预措施: BI 425809 (Drug)
Test
Experimental
multiple doses of Itraconazole + single dose BI 425809
干预措施: BI 425809 (Drug)
Test
Experimental
multiple doses of Itraconazole + single dose BI 425809
干预措施: Itraconazole (Drug)
结局指标
主要结局
AUC0-167 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 167 h)
时间窗: 8 days postdose
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: 15 days postdose
次要结局
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(15 days postdose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female SubjectsPharmacokineticsDDI (Drug-Drug Interaction)Healthy SubjectsNCT02175407Astellas Pharma Europe B.V.14
已完成
1 期
Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy SubjectsHealthy SubjectsNCT04479891Jiangsu HengRui Medicine Co., Ltd.18
已完成
1 期
Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy ParticipantsHealthyNCT05203822Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany18
已完成
1 期
A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult ParticipantsHealthy ParticipantsNCT05154136Arcus Biosciences, Inc.20
已完成
1 期
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy ParticipantsHealthy VolunteersNCT03774576Hoffmann-La Roche14