NCT03774576已完成1 期
A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
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
- 14
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax) of RO7017773 in Plasma
研究概览
简要总结
The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.
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 55 Years（Adult）
- 性别
- All
- 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
RO7017773
Experimental
Single dose of RO7017773
干预措施: RO7017773 (Drug)
RO7017773 and Itraconazole
Experimental
Single dose of RO7017773 and multiple doses of itraconazole
干预措施: RO7017773 (Drug)
RO7017773 and Itraconazole
Experimental
Single dose of RO7017773 and multiple doses of itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Concentration (Cmax) of RO7017773 in Plasma
时间窗: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)
次要结局
- Percentage of Participants With Adverse Events (AEs)(12 weeks)
- Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)(From screening visit through Period 2 Day 11)
- Cmax of Itraconazole in Plasma(Period 2)
研究者
研究点 (1)
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