NCT04843449已完成1 期
A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC of ASC40
研究概览
简要总结
The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.
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
- •19kg/m2 ≤ BMI <40kg/m
排除标准
- •History of, or current digestive system, nervous system disease, etc..
- •Taking drugs or foods that inhibit or induce the liver's metabolism.
研究组 & 干预措施
Inhibitor group
Experimental
- ASC40 50mg, once daily on the 1st and 11th days before meal;
- Itraconazole 200mg, once daily from the 6th day to the 15th day.
干预措施: ASC40 (Drug)
Inhibitor group
Experimental
- ASC40 50mg, once daily on the 1st and 11th days before meal;
- Itraconazole 200mg, once daily from the 6th day to the 15th day.
干预措施: Itraconazole (Drug)
Inducer group
Experimental
- ASC40 50mg, once daily on the 1st and 19th days before meal;
- Rifampicin 600mg, once daily from the 6th day to the 19th day.
干预措施: ASC40 (Drug)
Inducer group
Experimental
- ASC40 50mg, once daily on the 1st and 19th days before meal;
- Rifampicin 600mg, once daily from the 6th day to the 19th day.
干预措施: rifampicin (Drug)
结局指标
主要结局
AUC of ASC40
时间窗: Up to 24 days
Evaluate the Area under the Plasma Concentration Versus Time Curve after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Cmax of ASC40
时间窗: Up to 24 days
Evaluate the Peak Plasma Concentration after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
次要结局
- t1/2 of ASC40(Up to 24 days)
- CL/F of ASC40(Up to 24 days)
- Vd/F of ASC40(Up to 24 days)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 24 days)
研究者
研究点 (1)
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