Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe, Moderate and Mild) Compared With Matched Male and Female Participants With Normal Renal Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.
Iclepertin is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having kidney problems influences how iclepertin is taken up in the body. All participants take iclepertin once as a tablet.
Participants are in the study for 2 to 3 weeks. During this time, they visit the study site 6 times. For one of the visits, participants stay 4 nights at the study site. The site staff measures the amount of iclepertin in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.
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 —（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 4: Participants with normal renal function matching Group 3
干预措施: BI 425809 (Drug)
Group 1: Participants with severe renal impairment
干预措施: BI 425809 (Drug)
Group 2: Participants with normal renal function individually matched to participants of Group 1
干预措施: BI 425809 (Drug)
Group 3: Participants with moderate renal impairment
干预措施: BI 425809 (Drug)
Group 5: Participants with mild renal impairment
干预措施: BI 425809 (Drug)
Group 6: Participants with normal renal function matching Group 5
干预措施: BI 425809 (Drug)
结局指标
主要结局
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: Up to 7 days.
Maximum measured concentration of BI 425809 in plasma (Cmax)
时间窗: Up to 7 days.
次要结局
- Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)(Up to 7 days.)