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

Helsinn Healthcare SA0 sites24 target enrollmentJune 22, 2016

Overview

No summary available.

Registry

who.int

Start Date

June 22, 2016

End Date

July 31, 2015

Last Updated

7 years ago

Study Type

Interventional

Sex

Male

Sponsor

•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

•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