An Open-label Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Alisporivir (DEB025) in Subjects With End Stage Renal Disease on Hemodialysis Compared to Matched Healthy Subjects
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
- Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax)
研究概览
简要总结
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent before any assessment is performed
- •Matched healthy participants are in good health as determined by past medical history, physical examination, vital signs, laboratory tests, and other assessments
- •ESRD participants are on a protocol-defined stable hemodialysis regimen and have no evidence of hepatic decompensation, with vital signs and other tests within protocol-specified limits
- •Weighs at least 50 kg
- •Is able to communicate well with the investigator, to understand and comply with the requirements of the study.
排除标准
- •Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- •Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •the safety or well-being of the participant or study staff;
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- •the analysis of results
研究组 & 干预措施
End stage renal disease participants
End stage renal disease (ESRD) participants received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food at any time during the 2 hours after completion of hemodialysis on Day 1.
干预措施: Alisporivir (Drug)
Matched healthy participants
Healthy participants (matched to those with end stage renal disease by sex, age, weight, and smoking status), received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food on Day 1.
干预措施: Alisporivir (Drug)
结局指标
主要结局
Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax)
时间窗: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Area under the plasma concentration-time curve for alisporivir from time zero to time 'infinity' [mass x time / volume] (AUCinf)
时间窗: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Area under the plasma concentration-time curve for alisporivir from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUClast)
时间窗: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
次要结局
- Time to reach peak or maximum concentration of alisporivir following drug administration [time] (Tmax)(Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose)
- The terminal elimination half-life [time] (T1/2) for alisporivir(Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose)
- Apparent systemic (or total body) clearance from plasma following extravascular administration of alisporivir [volume / time] (CL/F)(Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose)
- The apparent volume of distribution during the terminal elimination phase following extravascular administration of alisporivir [volume] (Vz/F)(Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose)