A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): AUC(0-t)
研究概览
简要总结
This study will be a single center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 2 parts. In Part A, the effects of steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will be sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in equal numbers (approximately 15 subjects per group). The itraconazole treatment group will be fully enrolled before enrollment is initiated for the rifampin treatment group. In Part B, the effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a substrate of CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately 24 subjects. The 2 study parts can be conducted in parallel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
E2006 Part A
E2006 10-mg tablets alone and in combination with rifampin 600 mg or itraconazole 200 mg
干预措施: rifampin 600 mg (Drug)
E2006 Part A
E2006 10-mg tablets alone and in combination with rifampin 600 mg or itraconazole 200 mg
干预措施: itraconazole 200 mg (Drug)
E2006 Part A
E2006 10-mg tablets alone and in combination with rifampin 600 mg or itraconazole 200 mg
干预措施: E2006 (Drug)
E2006 Part B
E2006 10-mg tablets alone and in combination with midazolam 2 mg plus bupropion 75 mg
干预措施: midazolam 2 mg with bupropion 75 mg (Drug)
E2006 Part B
E2006 10-mg tablets alone and in combination with midazolam 2 mg plus bupropion 75 mg
干预措施: E2006 (Drug)
结局指标
主要结局
Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): AUC(0-t)
时间窗: Approximately 56 Days for Part A; Approximately 42 Days for Part B
Area under the concentration-time curve from zero time to time of last quantifiable concentration
Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): AUC(0-inf)
时间窗: Approximately 56 Days for Part A; Approximately 42 Days for Part B
Area under the concentration-time curve from zero time extrapolated to infinite time
Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): Cmax
时间窗: Approximately 56 Days for Part A; Approximately 42 Days for Part B
Maximum observed concentration
次要结局
- Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): tmax(Approximately 56 Days for Part A; Approximately 42 Days for Part B)
- Pharmacokinetics of E2006: AUC(0-8h)(Approximately 56 Days for Part A; Approximately 42 Days for Part B)
- Pharmacokinetics of E2006: AUC(0-24h)(Approximately 56 Days for Part A; Approximately 42 Days for Part B)
- Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): AUC(0-72h)(Approximately 56 Days for Part A; Approximately 42 Days for Part B)
- Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): t1/2(Approximately 56 Days for Part A; Approximately 42 Days for Part B)
- Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): CL/F(Approximately 56 Days for Part A; Approximately 42 Days for Part B)
- Pharmacokinetics of E2006 and its major metabolites, M4, M9, and M10 (Part A), and midazolam, bupropion, and the hydroxylated metabolite of bupropion (Part B): AUC(0-inf), metabolite ratio(Approximately 56 Days for Part A; Approximately 42 Days for Part B)