NCT00856869已完成1 期
A Study in Healthy Volunteers and Patients With Liver Cirrhosis and Non-Alcoholic Steatohepatitis (NASH) to Assess the Effects of Age, Gender, Chronic Liver Disease, and Prandial Effects on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) an 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 52 人开始时间: 2004年8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
- 52
- 试验地点
- 1
- 主要终点
- Clearance of NRL972 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.
研究概览
简要总结
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide information on the safety and tolerability of repeated intravenous doses of NRL972 in these populations.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General - all subjects
- •Males or females (females of non-childbearing potential or of childbearing 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) e.g. > 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 Nonalcoholic steatohepatitis (NASH)
- •Age: 18 - 75 years
- •Diagnosis of NASH confirmed by liver biopsy
排除标准
- •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 450 mL within the last 3 months
- •History of any clinically relevant allergy
- •Uncontrolled diabetes mellitus or any further intolerability of the Galactose test
- •Presence of acute or chronic infection
- •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
- •Clinically relevant ECG-abnormalities that constitute a contraindication for the Lido-cain-MEG'-X-test
- •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 (list of past and present diseases will be reviewed by an expert panel)
- •Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes, reduced serum creatinine (laboratory test abnormalities will be reviewed by an expert panel)
- •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
- •Fluctuating or rapidly deteriorating hepatic function
- •Significant bleeding diathesis
- •Oesophageal bleeding within the last 8 weeks before study entry
- •Ascites > 6 L on abdominal US
- •Number Connection test: time to connect 25 consecutive numbers > 30 sec
- •Presence or history of any relevant comorbidity other than hepatic disease (list of past and present diseases will be reviewed by an expert panel)
- •Clinically relevant abnormal laboratory values other than those associated or sufficiently explained by the existing liver disease (laboratory test abnormalities will be reviewed by an expert panel)
- •History of drug or alcohol abuse within 2 months prior to dosing
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 NASH
Experimental
Patients with presumed NASH
干预措施: NRL972 (Drug)
6 CTP-A
Experimental
Patients with hepatic cirrhosis CTP-class A
干预措施: NRL972 (Drug)
7 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 after a standard meal and while fasted in healthy volunteers, patients with NASH and patients with hepatic cirrhosis.
时间窗: Up to 4 hours post administration of NRL972
次要结局
- Adverse events and changes in physical findings from baseline(Up to 4 hours post-dosing)
- Effects of 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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