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Pharmacokinetics of LCQ908 in Patients With Renal Impairment

2020年12月16日 更新者：Novartis Pharmaceuticals

An Open-label, Parallel-group, Single Dose Study to Assess the Pharmacokinetics of LCQ908 in Patients With Mild, Moderate and Severe Renal Impairment Compared to Age, Gender and Weight-matched Healthy Volunteers.

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

58

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。

学习地点

  • 美国
    • Florida
      • Orlando、Florida、美国、32809
        • Novartis Investigative Site
    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • Novartis Investigative Site

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 75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:

  • Individuals with renal impairment only

    • Estimated Creatinine Clearance (CLcr) by the Cockroft-Gault equation ≤80mL/min;
    • Mild renal impairment defined as CLcr 50-80 mL/min
    • Moderate renal impairment defined as CLcr 30-50 mL/min
    • Severe renal impairment defined as CLcr <30 mL/min
  • Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation >80mL/min

Exclusion Criteria:

  • All Individuals

    • A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
    • Female subjects must be of non child bearing potential or use an effective method of contraception.

  • Individuals with renal impairment

    • Renal transplant at any time.
    • Subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months.
    • History of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days.
    • Any medication that is contraindicated in moderate or severe renally impaired population

  • Healthy subjects

    • History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria)
    • Evidence of urinary obstruction or difficulty in voiding at screening
    • History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

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
  • 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：LCQ908 (mild renal impairment plus healthy volunteers)
Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with mild renal impairment and will receive a single 40 mg dose of LCQ908.
药品：LCQ908
Participants will receive a single oral dose of LCQ908
实验性的：LCQ908 (moderate renal impairment plus healthy volunteers)
Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with moderate renal impairment and will receive a single 40 mg dose of LCQ908.
药品：LCQ908
Participants will receive a single oral dose of LCQ908
实验性的：LCQ908 (severe renal impairment plus healthy volunteers)
Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with severe renal impairment and will receive a single 40 mg dose of LCQ908.
药品：LCQ908
Participants will receive a single oral dose of LCQ908

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Maximum plasma concentration (Cmax) of LCQ908
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

次要结果测量

结果测量
措施说明
大体时间
Number of participants with adverse events (AEs), serious adverse events (SAEs) and death
大体时间：Day 29
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital abnormalities or birth defects, or are other conditions which in the judgment of investigators represent significant hazards.
Day 29
The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Time to maximum plasma concentration of LCQ908
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
The time required for the concentration of the drug to reach half of its original value
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration
大体时间：Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908
大体时间：10 and 24 hours
10 and 24 hours
LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908
大体时间：10 and 24 hours
10 and 24 hours
LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration
大体时间：10 and 24 hours
10 and 24 hours

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。

赞助

Novartis Pharmaceuticals

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。

有用的网址

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

2012年5月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2012年3月14日

首先提交符合 QC 标准的

2012年3月19日

首次发布 (估计)

2012年3月20日

研究记录更新

最后更新发布 (实际的)

2020年12月19日

上次提交的符合 QC 标准的更新

2020年12月16日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CLCQ908B2102

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