A Clinical Trail to Investigate the Influence of SLCO2B1 Polymorphism on the Pharmacokinetic Characteristics of Voriconazole in CYP2C19 Poor Metabolizers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic outcome - Maximum plasma concentration (Cmax)
研究概览
简要总结
A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer who is a CYP2C19 Poor metabolizer with rs3781727 SNP wild or variant genotype
排除标准
- •History of clinically significant respiratory, cardiovascular, renal, hepatic, hematologic, neurological disorder
研究组 & 干预措施
SLCO2B1 wild type
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
干预措施: Vfend (voriconazole) intravenous infusion (Drug)
SLCO2B1 wild type
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
干预措施: Vfend (voriconazole) tablet (Drug)
SLCO2B1 variant
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
干预措施: Vfend (voriconazole) intravenous infusion (Drug)
SLCO2B1 variant
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
干预措施: Vfend (voriconazole) tablet (Drug)
结局指标
主要结局
Pharmacokinetic outcome - Maximum plasma concentration (Cmax)
时间窗: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose
Pharmacokinetic outcome - Area under the plasma concentration versus time curve (AUC)
时间窗: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose
次要结局
未报告次要终点
研究者
SeungHwan Lee
Assistant Professor
Seoul National University Hospital