The Food-effect on Alectinib Pharmacokinetics

The goal of this food-effect study on Alectinib pharmacokinetics is to learn about the food effect of alectinib. The main question aims to answer is:• To determine the food-effect of a standardized Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®), especially Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC) and relative bioavailability, at steady state using a stable isotopically labelled microtracer approach.Participants will take alectinib-d6 (microtracer) with and without food on different days.

Inclusion Criteria:Currently treated with alectinib for NSCLC or other oncological indications;On alectinib treatment at a stable dose of 600 mg twice daily (≥ 7 days) according to standard of careAge ≥ 18 years;Able and willing to give written informed consent;world health organization (WHO) performance status of 0,1 or 2;Able and willing to undergo blood sampling for pharmacokinetic analysis;Able and willing to get one intravenous line for pharmacokinetic samplingAble and willing to comply with study restrictions and to remain at the study center for the required duration.Able and willing to undergo the defined food interventionsExclusion Criteria:Any treatment with investigational drugs (alectinib-d6) within 30 days or 5 half-lives prior to receiving the investigational treatment;Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir and voriconazole), inhibitors of Pgp (e.g. cyclosporine, kinidine, and verapamil), inhibitors of breast cancer resistance protein (BCRP) (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP;Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of alectinib (e.g. inflammatory bowel disease, gastric bypass).