Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine
2009年3月5日 更新者:Norgine
A Single-Centre, Open, Controlled, Randomised Cross-Over Study in Healthy Male and Female Volunteers to Evaluate the Pharmacokinetics of Cholyl-Lysyl-Fluorescein (NRL972) in the Presence of Medication-Induced Changes in Cytochrome P450 or Biliary Transporter Proteins. Part A: Interaction With Rifampicin and Cyclosporine
A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.
研究概览
研究类型
介入性
注册 (实际的)
12
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
-
-
-
Sofia、保加利亚、1527
- Dept. Clinical Pharmacology & Therapeutics, MHAPT "Zaritza Johanna" University Hospital
-
-
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
21年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- Caucasian
- Age: 21 - 40 years
- BW 50 - 100 kg
- BMI 20 - 26 kg.m-2
- healthy based on the pre-study examination
- willing and able to provide informed consent
Exclusion Criteria:
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 (including hypersensitivity to the trial medications)
- Presence of acute or chronic infection
- Presence or history of any relevant co-morbidity
- 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
- Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
- Positive serology for HBsAg, anti HBc and anti HCV
- Positive HIV test
- Positive alcohol or urine drug test on recruitment (and upon admission)
- History of alcohol and/or drug abuse and/or 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 understand the information in this regard
General - all females
- Positive pregnancy test
- Lactating
- Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods [condom, diaphragm with spermacide gel] should be used in addition).
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:诊断
- 分配:随机化
- 介入模型:交叉作业
- 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:T1
Pre-treatment with rifampicin
|
Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
Reference test: Single intravenous administration of 2 mg NRL972
Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
|
实验性的:T2
Pre-treatment with cyclosporin
|
Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
Reference test: Single intravenous administration of 2 mg NRL972
Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
|
实验性的:Reference
Administration of NRL001 alone: no pre-treatment
|
Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
Reference test: Single intravenous administration of 2 mg NRL972
Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
大体时间:Up to 6 hours post dose
|
Up to 6 hours post dose
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Non-compartmental PK-analysis based on the extensive profile (up to last quantifiable data point), the 'short' profile (over the first hour after injection), and the two-point profile based on selected data-pairs over the 1st hour after dosing
大体时间:Up to 6 hours post dose
|
Up to 6 hours post dose
|
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
调查人员
- 研究主任:Hans J Gruss, MD、Norgine Ltd
- 首席研究员:Emil Gatchev, PD Dr、MHAPT "Zaritza Johanna" University Hospital
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
2006年6月1日
初级完成 (实际的)
2006年7月1日
研究完成 (实际的)
2006年8月1日
研究注册日期
首次提交
2009年3月5日
首先提交符合 QC 标准的
2009年3月5日
首次发布 (估计)
2009年3月6日
研究记录更新
最后更新发布 (估计)
2009年3月6日
上次提交的符合 QC 标准的更新
2009年3月5日
最后验证
2009年3月1日
更多信息
与本研究相关的术语
其他研究编号
- NRL972-04A/2005 (IN-A)
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
-
Cairo UniversityAhmed Elgazzar Hospital完全的