NCT04024332已完成1 期
A Single-center, Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-541468 in Subjects With Severe Renal Impairment Compared to Healthy Subjects
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
- AUC of ACT-541468 from time zero to 24 h after study drug administration (AUC0-inf)
研究概览
简要总结
Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older 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
Group A (healthy)
Experimental
On Day 1, 8 healthy subjects will receive a single oral dose of 25 mg ACT-541468 in fasted condition.
干预措施: ACT-541468 (Drug)
Group B (severe renal function impairment)
Experimental
On Day 1, 8 subjects with severe renal function impairment will receive a single oral dose of 25 mg ACT-541468 in fasted condition.
干预措施: ACT-541468 (Drug)
结局指标
主要结局
AUC of ACT-541468 from time zero to 24 h after study drug administration (AUC0-inf)
时间窗: Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days
次要结局
- Number of subjects with treatment-emergent (serious) adverse events (S)AEs(During treatment with ACT-541468 administration for a total duration of up to 4 days)
研究者
研究点 (1)
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