ISRCTN93845260已完成1 期
Pharmacokinetic drug-drug interaction study between oral 300 mg netupitant/0.50 mg palonosetron fixed dose combination (Akynzeo®) and oral dexamethasone. Evaluation of the duration of the CYP3A4 inhibition in a randomized, two-period, two-sequence, crossover study in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Informed consent: signed written informed consent before inclusion in the study
- •2. Gender and age: male subject, 18-50 year old inclusive
- •3. Health conditions: general good health, based upon the results of the medical history, physical examination, vital signs and ECG measurements
- •4. Body weight: body weight = 50 kg and body mass index between 18.5 and 30 kg/m2 inclusive
- •5. Tobacco: non-smoker or having stopped smoking and using other products containing nicotine for at least 6 months before screening
- •6. Hemoglobin and ferritin: 14 g/dL=hemoglobin=18 g/dL and ferritin>30 ng/mL measured at the screening visit
- •7. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, pulse rate 50-90 bpm, measured after 5 min at rest in the sitting position
- •8. Full comprehension: ability to understand the nature of the study and willing to comply with the protocol requirements
排除标准
- •1. Investigative drug studies: participation in any investigational trial within 3 months before the planned first study drug administration in the study
- •2. Netupitant studies: enrolment in a previous study of netupitant (alone or in combination with palonosetron)
- •3. Allergy: history of significant allergies (including asthma, food, or drug allergies), as determined by the investigator
- •4. Hypersensitivity: history of hypersensitivity to any of the study treatments or to any of their excipients
- •5. Blood donation: having significant blood losses or having donated or received blood within 90 days before the planned first study drug administration in the study or during the study
- •6. Medications: receiving any prescription or over-the-counter medications or vitamins or herbal supplements within 21 days before the planned first study drug administration in the study and during the whole study
- •7. CYP3A4 inducers and inhibitors: use of any inducer or inhibitor of CYP3A4 enzymes within 28 days before the planned first study drug administration in the study and during the whole study
- •8. Drug: history of drug abuse
- •9. Alcohol: history of alcohol abuse [>2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010]
- •10. Alcohol test: positive alcohol breath test at the screening visit or Day -1 of each treatment period
- •11. Clinical conditions: any clinical condition or prior therapy that, in the investigator’s opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
- •12. Fever and infections: febrile or infectious illness within 7 days before the planned first study drug administration in each treatment period
- •13. Malabsorption: any condition which might interfere with the absorption of the investigational medicinal products (e.g. cholecystectomy, cholecystolithiasis)
- •14. Contraindications: known contraindication to NK-1 receptor antagonists and/or 5-HT3 receptor antagonists and/or dexamethasone
- •15. Xanthines: excess in consumption of xanthine-containing food or beverages (i.e., more than 5 cups of coffee or equivalent per day) within 48 hours before the planned first study drug administration in the study and during the whole study (including wash-out period)
- •16. Diet and life style: intake of alcohol or food (as grapefruit juice) known to interfere with cytochrome P450 (CYP) within 168 hours (1 week) before the planned first study drug administration in the study and during the whole study
- •17. Laboratory analyses: clinically significant abnormal laboratory values of hematology, clinical blood chemistry or urine analysis (dipstick) indicative of physical illness
- •18. Creatinine: creatinine clearance, calculated using the Cockcroft-Gault formula, >1.5 times the upper normal limit
- •19. Virology: positive laboratory test results for hepatitis B surface antigen, hepatitis C virus antibodies or human immunodeficiency virus
- •20. Abuse drug test: positive urine drug test results (dipstick test for cocaine, amphetamine, methamphetamine, cannabinoids, opiates and ecstasy) at the screening visit or Day -1 of each treatment period
- •21. Electrocardiogram (ECG) 12-leads
研究者
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