A Single-dose, Open-label Parallel Study to Assess the Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Area under the serum concentration-time curve from time zero to infinity (AUCinf)
研究概览
简要总结
This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.
20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
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 70 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
RLX030: Group 4 - healthy volunteers
Participants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3.
干预措施: RLX030A (Drug)
RLX030: Group 1 mild hepatic impairment
Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030
干预措施: RLX030A (Drug)
RLX030: Group 2 moderate hepatic impairment
Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030
干预措施: RLX030A (Drug)
RLX030: Group 3 severe hepatic impairment
Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030
干预措施: RLX030A (Drug)
结局指标
主要结局
Area under the serum concentration-time curve from time zero to infinity (AUCinf)
时间窗: Up to Day 15
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: Up to Day 15
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Serum concentration at 24 hour (C24h) after administration
时间窗: Upto Day 15
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
次要结局
- Number of patients with adverse events, serious adverse events and death(Day 15)
- Terminal elimination half life (T ½) of RLX030(screening, days 1, 2, 3, 4 and 15)
- Systemic clearance of RLX030 from serum (CL)(screening, days 1, 2, 3, 4 and 15)
- Volume of distribution at steady state (Vss)(screening, days 1, 2, 3, 4 and 15)
- Determination of the presence and quantification of anti-RLX030 antibodies(Day 1 (prior to administration) and Day 15 end of study)
- Mean residence time [MRT] of RLX030(screening, days 1, 2, 3, 4 and 15)