Inhibitory effect on CYP3A4 Not Applicable
Conditions
Interventions
During the trial the following investigational medicinal products (IMPs) were administered:
1. Akynzeo , netupitant/palonosetron 300mg/0.50 mg fixed dose combination: interacting drug
Sponsors
Helsinn Healthcare SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the pharmacokinetic profile of oral dexamethasone on Days 1, 4, 6, 8 and 10 with and without co-administration of a single dose of NEPA FDC on Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe the plasma pharmacokinetic profile of netupitant and palonosetron 2. To collect safety and tolerability data | — |
Countries
Switzerland
Outcome results
None listed