Evaluation and Validation of Metabolic Markers for the Assessment of CYP3A Activity and Prediction of Drug-drug Interaction in Korean Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Quantitation of endogenous metabolites
研究概览
简要总结
Evaluation and validation of metabolic markers for the assessment of CYP3A activity and prediction of drug-drug interaction in Korean healthy subjects.
详细描述
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Urine collection is scheduled drug 12 hour before and 24 hour after midazolam administration. Subjects will be dosed study drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures.
In period 2, Subjects will be admitted on Day 3-5. Subjects performed scheduled period 2 (Itraconazole co-administration phase, 2 times administration of itraconazole 200 mg), and period 3 (rifampicin 150 mg co-administration phase) procedure. Study participation was terminated on post-study visit (Day 23~35).
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
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: Between 20 to 40 years of age, inclusive
- •Weight: within 17-28 of Body Mass Index (BMI)
- •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, itraconazole, 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
- •Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
- •Participation in clinical trials of any drug within 60 days prior to the participation of the study
- •Judged to be inappropriate for the study by the investigator
研究组 & 干预措施
midazolam alone
midazolam administration alone
干预措施: Midazolam (Drug)
midazolam and itraconazole
Itraconazole 200 mg PO twice; midazolam iv single administration
干预措施: Midazolam (Drug)
midazolam and itraconazole
Itraconazole 200 mg PO twice; midazolam iv single administration
干预措施: itraconazole (Drug)
midazolam and rifampicin
rifampicin 150 mg PO for 9 days administration, midazolam iv single administration
干预措施: Midazolam (Drug)
midazolam and rifampicin
rifampicin 150 mg PO for 9 days administration, midazolam iv single administration
干预措施: rifampicin (Drug)
结局指标
主要结局
Quantitation of endogenous metabolites
时间窗: -12h-24h
endogenous metabolite profiles such as steroids to predict CYP3A activity
Maximum plasma concentration and area under the cure from zero to last point
时间窗: Time Frame: 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h
Cmax, AUClast of midazolam
次要结局
未报告次要终点
研究者
Joo-Youn Cho
Professor
Seoul National University Hospital