NCT04479891已完成1 期
A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib 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
- 18
- 试验地点
- 1
- 主要终点
- Cmax of pyrotinib
研究概览
简要总结
The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- •Able to complete the study as required by the protocol;
- •Subjects have no birth plan and voluntarily take effective contraception from 2 weeks before administration to 3 months after the last dose, and the pre-drug serum HCG test for fertility-enabled women must be negative;
- •Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m2 ;
- •No clinically significant abnormalities in general physical examination, vital signs, laboratory tests, etc.
排除标准
- •Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
- •Allergic constitution or known allergy to pyrotinib, itraconazole or the excipients;
- •History of drug abuse in the past 5 years, or positive for drug abuse screening;
- •Alcoholic or often drinkers with drinking amount more than 14 units a week; a heavy smoker; and can't abstain from smoking and alcohol during the study
- •Left ventricular ejection fraction (LVEF) <50% by echocardiography or QTcF ≥ 470 msec by 12 lead electrocardiograph;
- •A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system that are not suitable for subjects to participate in the study, as judged by the investigator;
- •Any surgery within 6 months before screening;
- •Have taken hepatotoxic drugs for a long time within 6 months before screening;
- •Subjects who took any clinical trial drugs within 3 months;
- •Subjects who took any drugs that change liver enzymes activity within 28 days before dosing; or took any prescription drugs, over-the-counter drugs or vitamins, health products or herbal medicine within 14 days before dosing;
- •Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
- •Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing; strenuous exercise; or other factors which affect drug absorption, distribution, metabolism, excretion, etc.;
- •Other factors that are not suitable for subjects to participate in the study, as judged by the investigator.
研究组 & 干预措施
pyrotinib alone, pyrotinib + itraconazole
Experimental
Sequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between.
干预措施: pyrotinib tablet (Drug)
pyrotinib alone, pyrotinib + itraconazole
Experimental
Sequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between.
干预措施: Itraconazole capsule (Drug)
结局指标
主要结局
Cmax of pyrotinib
时间窗: Day 1 and Day 9
Maximum concentration (Cmax) of pyrotinib
AUC of pyrotinib
时间窗: Day 1 and Day 9
Area under the plasma concentration versus time curve of SHR6390
次要结局
- Tmax of pyrotinib(Day 1 and Day 9)
- T1/2 of pyrotinib(Day 1 and Day 9)
- AEs and SAEs(From the first drug administration to 7 days after the last drug administration)
研究者
研究点 (1)
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