Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Area under the curve of midazolam (AUC12h)
研究概览
简要总结
The study objective is to evaluate and validate of endogenous markers for the assessment of CYP3A activity in Korean healthy subjects using metabolomics.
In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total 25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects will be administered midazolam I.V. 1 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Between 20 to 80 years of age, inclusive
- •Weight: Between 45 to 95 kg, within 17 - 28 of Body Mass Index
- •Subject who agree contraception during the study
- •Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily
排除标准
- •History of hypersensitive reaction to medication (midazolam, ketoconazole, rifampicin)
- •History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease history or evidence of drug abuse
- •A subject whose lab test results are abnormal A subject whose systolic blood pressure is over 140 mmHg or below 90 mmHg and diastolic blood pressure is over 100 mmHg or below 50 mmHg
- •Presence or history of drug abuse or positive result in urine drug screening test
- •Blood donation during 2 months or apheresis during 1 month before the study Use any prescriptive medication
- •Use of alcohol over 21 units/weeks
- •Smoker who smoke more than 10 cigarettes per day
- •Participation in clinical trials of any drug within 60 days prior to the participation of the study
- •Use of grapefruit juice within 1 week before first dose
- •Use of caffeine drink within 3 days before first dose
- •Subject pregnant or breast-feeding
- •Judged to be inappropriate for the study by the investigator
研究组 & 干预措施
Male elderly adults
Arm 2: Male healthy volunteers aged over 45 years Midazolam (IV) on day 1
干预措施: Midazolam I.V. (Drug)
Male young adults
Arm 1: Male healthy volunteers aged from 20 to 45 years Midazolam (IV) on day 1
干预措施: Midazolam I.V. (Drug)
Female elderly adults
Arm 3: Female healthy volunteers aged over 45 years Midazolam (IV) on day 1
干预措施: Midazolam I.V. (Drug)
Female young adults
Arm 4: Female healthy volunteers aged 20 to 45 years Midazolam (IV) on day 1, Day 15
干预措施: Midazolam I.V. (Drug)
结局指标
主要结局
Area under the curve of midazolam (AUC12h)
时间窗: Up to 12 hours after midazolam administration
Pharmacokinetics of midazolam
Metabolic ratio of steroids
时间窗: 12h-12h
endogenous metabolite profiles such as steroid (6beta-hydroxy-cortisol/cortisol, 6beta-hydroxy-cortisone/cortisone)
Clearance (CL) of midazolam
时间窗: Up to 12 hours after midazolam administration
Pharmacokinetics of midazolam
次要结局
未报告次要终点
研究者
Joo-Youn Cho
Professor
Seoul National University Hospital