NCT04315493Unknown1 期
A Randomized, Open, Single-dose, Two-cycle, Double-sequence, Crossover Study to Investigate the Effects of a Low-fat Diet On the Pharmacokinetics of Healthy Chinese Adult Participants After Oral Administration of Pyrotinib Maleate Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 主要终点
- Pharmacokinetics parameter: Cmax of pyrotinib
研究概览
简要总结
The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets.
The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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;
- •Ability to complete the study as required by the protocol;
- •Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- •Have no fertility plan and agree to adopt effective contraceptive measures within 2 weeks before the first study drug administration and up to 3 months after the last study drug administration. Negative pregnancy test for women of child-bearing age before the first study drug administration;
- •Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m^2 (including 19 and 26);
- •During screening period, the comprehensive physical examination (vital signs and physical examination), routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation,etc), 12-lead electrocardiogram (ECG), chest X-ray, cardiac ultrasound, B ultrasound and other examination results must be within the normal range, or judged to be "no clinical significance (NCS)" if beyond the normal range;
排除标准
- •Blood donation within 3 months before the first drug administration and blood loss greater than 400 mL, or receiving blood transfusion;
- •Allergic constitution, including those with severe drug allergies or a history of drug allergies, or known allergy to the research drug;
- •History of drug use, or drug abuse screening positive; history of drug abuse within the past five years or have used drugs 3 months before the test;
- •Alcoholic or often drinkers (the average drinking amount is more than 14 units a week: 1 unit= 285 ml beer or 45 ml spirits or 100 ml wine; ≥5 cigarettes per day) and can't quit smoking and alcohol during the study; alcohol test positive;
- •The 12-lead ECG with female QTcF > 470ms or male QTcF > 450ms;
- •Left ventricular ejection fraction (LVEF) <50% by echocardiography;
- •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.
- •Those who have undergone any surgery within 6 months before screening;
- •Those who have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for a long time within the 6 months before screening;
- •Those who have taken any research drugs within 3 months before the first drug administration;
- •Use any drugs that changes liver enzyme activity within 4 weeks before the first drug administration;
- •Use any prescription or over-the-counter drug, any vitamin product, health supplement or herbal medicine within 2 weeks prior to first drug administration;
- •Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases;
- •HCV antibody positive, HIV antibody positive, HBsAg positive, and syphilis antibody positive;
- •Consumption of grapefruit or grapefruit-containing products, foods or beverages containing caffeine, xanthine, or alcohol within 48 hours before the first drug administration; strenuous exercise or other factors that effect on drug absorption, distribution, metabolism and excretion;
- •Have special requirements on diet and cannot comply with the diet and corresponding regulations provided by the test;
- •History of dizzy needles or blood dizziness; difficulty in venous blood collection or inability to tolerate venipuncture;
- •lactating women;
- •Other factors that are not suitable for participating in the study, as judged by the investigator.
研究组 & 干预措施
A
Experimental
干预措施: pyrotinib maleate fasted in P1, low-fat diet in P2 (Drug)
B
Experimental
干预措施: pyrotinib maleate low-fat diet in P1, fasted in P2 (Drug)
结局指标
主要结局
Pharmacokinetics parameter: Cmax of pyrotinib
时间窗: through study completion, an average of 28 days
Peak Plasma Concentration (Cmax) of pyrotinib
Pharmacokinetics parameter: AUC of pyrotinib
时间窗: through study completion, an average of 28 days
Area under the plasma concentration versus time curve (AUC) of pyrotinib
次要结局
- Pharmacokinetics parameter: CL/F of pyrotinib(through study completion, an average of 28 days)
- Pharmacokinetics parameter: Vz/F of pyrotinib(through study completion, an average of 28 days)
- Pharmacokinetics parameter: T1/2 of pyrotinib(through study completion, an average of 28 days)
- Pharmacokinetics parameter: Tmax of pyrotinib(through study completion, an average of 28 days)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(through study completion, an average of 28 days)
研究者
相似试验
已完成
1 期
A Food Effect Study of SHR2554 on Healthy Chinese Male Adult SubjectsHealthy Adult SubjectsNCT04335266Jiangsu HengRui Medicine Co., Ltd.20
已完成
1 期
A Food Effect Study of SHR1459 on Healthy Chinese Adult SubjectsHealthy Adult SubjectsNCT04291846Jiangsu HengRui Medicine Co., Ltd.28
已完成
1 期
A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy AdultsHealthy ParticipantsNCT05349864Pfizer12
已完成
1 期
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy SubjectsHealthy SubjectsNCT05843708Servier Bio-Innovation LLC64
已完成
1 期
The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult SubjectsAlzheimer DiseaseNCT05787041South China Center For Innovative Pharmaceuticals16