A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics for probe drugs by assessing plasma concentration
研究概览
简要总结
This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 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
Single-sequence 3-period
Period 1: napabucasin 240 mg BID on days 1-2 Period 2: cytochrome P450 probe drugs during days 1-4 Period 3: napabucasin 240 mg BID on days 1-11, cytochrome P450 probe drugs during days 6-9
干预措施: napabucasin (Drug)
Single-sequence 3-period
Period 1: napabucasin 240 mg BID on days 1-2 Period 2: cytochrome P450 probe drugs during days 1-4 Period 3: napabucasin 240 mg BID on days 1-11, cytochrome P450 probe drugs during days 6-9
干预措施: cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate (Drug)
结局指标
主要结局
Pharmacokinetics for probe drugs by assessing plasma concentration
时间窗: Predose and up to 7 days post dose
Pharmacokinetics for napabucasin by assessing plasma concentration
时间窗: Predose and up to 7 days post dose
次要结局
未报告次要终点