Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 685509 Over 28 Days in Patients With Mild and Moderate Hepatic Impairment and of Single Oral BI 685509 Dose Compared to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The percentage of subjects with drug-related Adverse Events (AEs) among different dose regimes over each up-titration
研究概览
简要总结
The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment [Child-Turcotte-Pugh (CTP) classification A and B] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose group 1
Low Dose
干预措施: BI 685509 (Drug)
Dose group 1
Low Dose
干预措施: Placebo (Drug)
Dose group 2
Medium Dose
干预措施: BI 685509 (Drug)
Dose group 2
Medium Dose
干预措施: Placebo (Drug)
Dose group 3
High Dose
干预措施: BI 685509 (Drug)
Dose group 3
High Dose
干预措施: Placebo (Drug)
Dose Group 4
Dose for healthy volunteers dependent on results from prior dose groups with patients
干预措施: BI 685509 (Drug)
Dose Group 4
Dose for healthy volunteers dependent on results from prior dose groups with patients
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage of subjects with drug-related Adverse Events (AEs) among different dose regimes over each up-titration
时间窗: Up to day 28
次要结局
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady)(Up to 72 hours)
- AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [AUCτ,ss will be AUC0-12,ss for bid dosing](Up to 72 hours)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable data point)(Baseline and Up to 72 hours)
- Cmax (maximum measured concentration of the analyte in plasma)(Up to 72 hours)
- Change from baseline in body weight(Baseline and Up to 28 days)
- Change from baseline in seated systolic blood pressure (SBP)(Baseline and Up to 28 days)
- Change from baseline in seated diastolic blood pressure (DBP)(Baseline and Up to 28 days)
- Change from baseline in heart rate (HR)(Baseline and Up to 28 days)