NCT00856752已完成1 期
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
Norgine1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年6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
- 12
- 试验地点
- 1
- 主要终点
- Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
- •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
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 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
- •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).
研究组 & 干预措施
T1
Experimental
Pre-treatment with rifampicin
干预措施: NRL972 (Drug)
T2
Experimental
Pre-treatment with cyclosporin
干预措施: NRL972 (Drug)
Reference
Experimental
Administration of NRL001 alone: no pre-treatment
干预措施: NRL972 (Drug)
结局指标
主要结局
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
时间窗: Up to 6 hours post dose
次要结局
- 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(Up to 6 hours post dose)
研究者
研究点 (1)
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