NCT02507167已完成1 期
Impact of Two Genetic Variants of OATP 1B3 or MRP 2 or Rifampin Mediated Transporter Inhibition on Systemic Disposition and Biological Efficacy of CCK-8 in 36 Healthy Male Individuals
University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年11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
- 19
- 试验地点
- 1
- 主要终点
- CCK-8
研究概览
简要总结
The purpose of this study is to evaluate the impact of genetic variants of OATP 1B3 or MRP 2 on the systemic disposition of endogenously formed CCK-8 and to determine the influence of a single-dose of the transporter inhibitor rifampin (600 mg) on the systemic disposition of endogenously formed CCK-8. Endogenous CCK-8 secretion will be induced by a single-dose standardized liquid mixed meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 18-45 years
- •sex: male
- •12 subjects being homozygote wild-type carriers of OATP 1B3 (c.SLCO 1B3 699 AA and c.SLCO 1B3 334 GG) and MRP 2
- •12 subjects being homozygotes of the MRP 2 variants (genetic loss of function) and homozygote wild-type carriers of OATP 1B3
- •12 subjects being homozygotes of the OATP 1B3 variants (c.SLCO 1B3 699 GG and c.SLCO 1B3 334 TT) and homozygotes wild-type carriers of MRP 2
- •BMI: ≥ 19 kg/m2 and ≤ 27 kg/m2
- •good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which will be judged by the clinical investigator not to differ in a clinical relevant way from the healthy state
- •written informed consent given by the volunteer after being provided with detailed information (both, verbally and written) about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
排除标准
- •hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
- •gastrointestinal diseases and/or pathological findings (e.g. stenoses), which might interfere with pharmacokinetics and pharmacodynamics of the study medication
- •subjects with existing dysfunction in regulation of glucose metabolism, e.g. deficiency of glucose-6-phosphate dehydrogenase (Glc-6-P DHG) and/ or pathological findings
- •subjects with alcohol and/ or drug dependence and a alcohol consumption more than 20 g alcohol/ day
- •excessive smoking (more than 10 cigarettes or equivalents/ day)
- •subjects with positive finding of HBsAG, HIV and/ or drugs
- •subjects being on a diet (inclusive special or uniform nutritional habits, e.g. vegetarians or undercaloric diet)
- •strong coffee and/ or tea consumption (≥ 1 liter a day)
- •subjects suspected or known not to follow instructions
- •subjects who are unable to understand written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •subjects liable to orthostatic dysregulation, fainting, or blackout
- •subjects who took part in other clinical trials in the last 3 months (blocking time due to another clinical trial with investigational products)
- •acute illness less than 14 d in the past
- •blood donation within the last 3 months
- •any medication within 4 weeks prior to the intended first administration of the study medication which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors, anticholinergics)
- •any other medication within 2 weeks prior to the first administration of the study medication or less than 10-time the half-live of the respective drug
- •intake of grapefruit containing food or beverages and poppy seeds containing products 14 d prior to the first drug administration until the last blood sampling of the study
研究组 & 干预措施
mixed meal
Placebo Comparator
干预措施: mixed meal (Dietary Supplement)
mixed meal 2 h after single dose rifampin (600 mg)
Active Comparator
干预措施: mixed meal (Dietary Supplement)
mixed meal 2 h after single dose rifampin (600 mg)
Active Comparator
干预措施: Rifampin (Drug)
结局指标
主要结局
CCK-8
时间窗: 3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal
Cholecystokinin amino acid 8 concentration in blood plasma
次要结局
- GIP(3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal)
- glucagon(3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal)
- glucose(3 h 15 min up to 2 h 15 min before and 15, 30, 45 min, 1, 1.25 h after mixed meal)
- GLP-1(3 h 15 min up to 2 h 15 min before and 5, 10, 15, 20, 25, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4 h after mixed meal)
- potassium(3 h 15 min up to 2 h 15 min before and 15, 30, 45 min, 1, 1.25 h after mixed meal)
- C-peptide(3 h 15 min up to 2 h 15 min before and 15, 30, 45 min, 1, 1.25 h after mixed meal)
- insulin(3 h 15 min up to 2 h 15 min before and 15, 30, 45 min, 1, 1.25 h after mixed meal)
研究者
研究点 (1)
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