NCT00856713已完成1 期
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
Norgine1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
- •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
排除标准
- •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
- •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
研究组 & 干预措施
1 YM
Experimental
Healthy young males
干预措施: NRL972 (Drug)
2 EM
Experimental
Healthy elderly males
干预措施: NRL972 (Drug)
3 YF
Experimental
Healthy young females
干预措施: NRL972 (Drug)
4 EF
Experimental
Healthy elderly females
干预措施: NRL972 (Drug)
5 CTP-A
Experimental
Patients with hepatic cirrhosis CTP-class A
干预措施: NRL972 (Drug)
6 CTP-BC
Experimental
Patients with hepatic cirrhosis CTP-class B and C
干预措施: NRL972 (Drug)
结局指标
主要结局
Clearance of NRL972 in healthy subjects and patients with hepatic cirrhosis
时间窗: Up to 4 hrs post administration of NRL972
次要结局
- Adverse events and changes in physical findings from baseline(Up to 4 hours post-dosing)
- Effects on vital signs: blood pressure, pulse rate(Up to 4 hours post-dosing)
- Effects on electrocardiogram(Up to 4 hours post-dosing)
- Changes in haematology, clinical chemistry, urinalysis(Up to 4 hours post-dosing)
研究者
研究点 (1)
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