Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
A Study in Healthy Volunteers and Patients With Liver Cirrhosis to Assess the Effects of Age, Gender, and Stable Liver Disease on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) as an in-Vivo Marker of Liver Function in Man
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Sofia、保加利亚、1431
- UMHAPT St Ivan Rilski's University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Subjects meeting the following conditions will be eligible for enrolment:
General - all subjects
- Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Caucasian
- BMI: between 19 and 34 kg.m-2
- BW: between 45 and 110 kg
willing and able to provide informed consent
Healthy volunteers (group N)
- Age: 18 - 40 years (inclusive) and > 60 years
Assessed as healthy based on the pre-study examination
Hepatic cirrhosis
- Age: 18 - 75 years
- stable compensated liver cirrhosis (cryptogenic, posthepatic, alcoholic) with histo-logical or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation
Exclusion Criteria:
Subjects of any of the following categories will be excluded from enrolment:
General - all subjects
- Previous participation in the trial
- Participant in any other trial during the last 90 days
- Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- History of any clinically relevant allergy
- Presence of acute or chronic infection
- Uncontrolled diabetes mellitus
- Resting systolic blood pressure > 160 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
- Positive HIV test
- Positive alcohol or urine drug test on recruitment
- Daily use of > 30 gr alcohol
- Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- Use of prohibited medication
- Suspicion or evidence that the subject is not trustworthy and reliable
Suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard
General - all females
- Positive pregnancy test
- Lactating
Not using appropriate contraception in premenopausal women
All healthy subjects
- Presence or history of any relevant comorbidity
- Presence of any relevant abnormality in the laboratory safety tests, especially low Hemoglobin, increased liver enzymes, reduced serum creatinine
- Positive serology for HBsAg, anti HBc and anti HCV
History of alcohol and/or drug abuse
Patients with hepatic disease
- Biliary liver cirrhosis
- Liver impairment due to space-occupying processes (e.g. carcinoma)
- State after liver transplantation or patient scheduled for liver transplantation
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 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:1 岁月
健康的年轻男性
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Single intravenous dose of 2 mg NRL972
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实验性的:2电磁
健康的老年男性
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Single intravenous dose of 2 mg NRL972
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实验性的:3 YF
健康的年轻女性
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Single intravenous dose of 2 mg NRL972
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实验性的:4英孚
健康的老年女性
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Single intravenous dose of 2 mg NRL972
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实验性的:5 CTP-A
Patients with hepatic cirrhosis CTP-class A
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Single intravenous dose of 2 mg NRL972
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实验性的:6 CTP-BC
Patients with hepatic cirrhosis CTP-class B and C
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Single intravenous dose of 2 mg NRL972
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis
大体时间:Up to 4 hrs post administration of NRL972
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Up to 4 hrs post administration of NRL972
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次要结果测量
结果测量 |
大体时间 |
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不良事件和身体检查结果相对于基线的变化
大体时间:给药后最多 4 小时
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给药后最多 4 小时
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对心电图的影响
大体时间:给药后最多 4 小时
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给药后最多 4 小时
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血液学、临床化学、尿液分析的变化
大体时间:给药后最多 4 小时
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给药后最多 4 小时
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Effects on vital signs: blood pressure, pulse rate
大体时间:Up to 4 hours post-dosing
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Up to 4 hours post-dosing
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合作者和调查者
赞助
调查人员
- 首席研究员:Zahariy Krastev, MD、St Ivan Rilski's University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
NRL972的临床试验
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Cairo UniversityAhmed Elgazzar Hospital完全的