A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics (PK) of single oral doses of E2609 and metabolites in subjects dosed alone or in combination with either rifampin or itraconazole
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 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in approximately 18 subjects. In Part C, the effects of donepezil administered in combination with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in approximately 24 subjects.
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
E2609
Experimental drug for Parts A, B, and C
干预措施: itraconazole (Drug)
E2609
Experimental drug for Parts A, B, and C
干预措施: rifampin (Drug)
E2609
Experimental drug for Parts A, B, and C
干预措施: digoxin (Drug)
E2609
Experimental drug for Parts A, B, and C
干预措施: donepezil (Drug)
itraconazole
Comparator drug for Part A1
干预措施: E2609 (Drug)
rifampin
Comparator drug for Part A2
干预措施: E2609 (Drug)
digoxin
Comparator drug for Part B
干预措施: E2609 (Drug)
donepezil
Comparator drug for Part C
干预措施: E2609 (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics (PK) of single oral doses of E2609 and metabolites in subjects dosed alone or in combination with either rifampin or itraconazole
时间窗: Up to 48 days (Part A)
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
To evaluate the PK of single oral doses of digoxin in subjects dosed alone or in combination with E2609
时间窗: Up to 48 days (Part B)
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
To evaluate the PK of single oral doses of E2609 and metabolites in subjects dosed alone, in combination with donepezil, or 2 hours before donepezil dosing
时间窗: Up to 86 day (Part C)
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
次要结局
- Safety and tolerability of single oral doses of E2609 in subjects in the presence and absence of rifampin, itraconazole, digoxin, or donepezil(Up to 182 days)
- To evaluate the effects of DNA sequence variants potentially involved in absorption, distribution and metabolism of E2609.(Up to 182 days)