NCT05147727已完成1 期
A Single-center, Open-label, Fixed-sequence Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of Famitinib 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
- 22
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax) for famitinib
研究概览
简要总结
An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.
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
- •With my consent and informed consent, I am willing and able to complete the study in accordance with the requirements of the experimental protocol;
- •Healthy male or female aged 18-45 years (including threshold) on the date of signing the informed consent form;
- •Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
- •Physical examination, vital signs, laboratory measurements (blood routine, blood biochemistry, urine routine test, coagulation function, etc.), 12-lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
- •Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 3 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 24 hours before the first administration of the study drug should be negative.
排除标准
- •Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
- •Subjects who have received any previous operation affecting gastrointestinal absorption;
- •Subjects who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
- •Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
- •HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive;
- •History of drug use in the past 5 years or drug abuse, or drug screening positive;
- •Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
- •Subjects who have swallowing resistance or obstacle that will affect the drug absorption;
- •Allergic constitution, including severe drug allergy or drug allergy history; known allergy to fluconazole and famitinib or its excipients;
- •Those who have participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
- •Inducers or inhibitors of CYP3A4 were taken within 4 weeks before the first administration of study drug;
- •Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
- •Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 48 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
- •Lactating women;
- •The researchers considered that the subjects had any other factors that were not suitable for the trial.
研究组 & 干预措施
Fluconazole and Famitinib interaction
Experimental
干预措施: Fluconazole、Famitinib (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax) for famitinib
时间窗: Day 1 to Day 25
Area under the concentration-time curve from time zero to time t (AUC0-t,) for famitinib
时间窗: Day 1 to Day 25
Area under the concentration-time curve extrapolated to infinity (AUC0-∞.) for famitinib (if applicable)
时间窗: Day 1 to Day 25
次要结局
- Time to elimination half-life (t1/2) for famitinib(Day 1 to Day 25)
- Apparent oral clearance (CL/F) for famitinib(Day 1 to Day 25)
- Time to maximum observed serum concentration (Tmax) for famitinib(Day 1 to Day 25)
- Apparent Volume of Distribution (Vz/F) for famitinib(Day 1 to Day 25)
- Tmax for famitinib metabolite SHR116637(Day 1 to Day 25)
- Cmax for famitinib metabolite SHR116637(Day 1 to Day 25)
- AUC0-t, for famitinib metabolite SHR116637(Day 1 to Day 25)
- AUC0-∞. for famitinib metabolite SHR116637(if applicable)(Day 1 to Day 25)
- t1/2 for famitinib metabolite SHR116637(Day 1 to Day 25)
- The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0)(Day 1 to Day 25)
研究者
研究点 (1)
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