Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
2020年12月17日 更新者：Novartis Pharmaceuticals
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
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.
研究概览
研究类型
介入性
注册 (实际的)
55
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion criteria:
All subjects:
• Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment
Subjects with hepatic impairment:
- Subjects must have either mild, moderate or severe hepatic impairment
Exclusion criteria:
All subjects
- Hepatic impairment due to non-liver disease
- Use of other investigational drugs at time of enrollment
- History of malignancy of any organ system
- Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing
- Hemoglobin levels below 10.0 g/dL at screening or baseline
Subjects with hepatic impairment:
- Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
- Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist
- Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs
Other protocol-defined inclusion/exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：RLX030: Group 1 mild hepatic impairment
Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030
|
RLX030 is administered as a continuous 24 hour infusion
|
|
实验性的：RLX030: Group 2 moderate hepatic impairment
Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030
|
RLX030 is administered as a continuous 24 hour infusion
|
|
实验性的：RLX030: Group 3 severe hepatic impairment
Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030
|
RLX030 is administered as a continuous 24 hour infusion
|
|
有源比较器：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.
|
RLX030 is administered as a continuous 24 hour infusion
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area under the serum concentration-time curve from time zero to infinity (AUCinf)
大体时间：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
|
Up to Day 15
|
|
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
大体时间：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
|
Up to Day 15
|
|
Serum concentration at 24 hour (C24h) after administration
大体时间：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
|
Upto Day 15
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of patients with adverse events, serious adverse events and death
大体时间：Day 15
|
Monitoring of adverse events, serious adverse events and death from screening to end of study
|
Day 15
|
|
Determination of the presence and quantification of anti-RLX030 antibodies
大体时间：Day 1 (prior to administration) and Day 15 end of study
|
Blood will be collected and serum analyzed for the presence of antiRLX030 antibodies.
Anti-RLX030 antibodies will be evaluated in serum in a validated four-tiered assay approach
|
Day 1 (prior to administration) and Day 15 end of study
|
|
Mean residence time [MRT] of RLX030
大体时间：screening, days 1, 2, 3, 4 and 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
|
screening, days 1, 2, 3, 4 and 15
|
|
Terminal elimination half life (T ½) of RLX030
大体时间：screening, days 1, 2, 3, 4 and 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
|
screening, days 1, 2, 3, 4 and 15
|
|
Systemic clearance of RLX030 from serum (CL)
大体时间：screening, days 1, 2, 3, 4 and 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
|
screening, days 1, 2, 3, 4 and 15
|
|
Volume of distribution at steady state (Vss)
大体时间：screening, days 1, 2, 3, 4 and 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
|
screening, days 1, 2, 3, 4 and 15
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年7月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年8月9日
首先提交符合 QC 标准的
2011年9月12日
首次发布 (估计)
2011年9月14日
研究记录更新
最后更新发布 (实际的)
2020年12月21日
上次提交的符合 QC 标准的更新
2020年12月17日
最后验证
2013年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.