effect of tepotinib on the pk of the p-gp substrate dabigatran etexilate

Conditions: Healthy

Summary: this study investigated the effect of tepotinib on the pharmacokinetics (pk) of the p-glycoprotein (p-gp) probe substrate dabigatran etexilate.


Eligibility criteria:
inclusion criteria: * healthy participants of non-child bearing potential * body weight between 50 to 100 kilogram (kg) * body mass index (bmi) between 18.5 and 29.9 kilogram per meter square (kg/m\^2) * a male participant must agree to use and to have his female partner of childbearing potential to use highly effective method of contraception * participant must have given written informed consent before any study-related activities * all values for hematology, coagulation, and biochemistry tests of blood and urinalysis are within the normal range. minor (solitary) non-clinically relevant deviation(s) are allowed as judged by the investigator * other protocol defined inclusion criteria could apply exclusion criteria: * participation in a clinical study within 60 days prior to first drug administration * whole blood donation or loss of \> 450 milliliter (ml) within 60 days prior to first drug administration * any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation * supine systolic blood pressure (sbp) greater than (\>) 140 millimeter of mercury (mmhg) or less than (\ 90 or \ 90 or \<50 beats per minute (bpm) at screening and at admission on day-1. * 12-lead electrocardiograms (ecg) showing a corrected qt interval per fridericia's formula (qtcf) \> 450 milliseconds (ms), pr \> 215 ms, or qrs \> 120 ms (at screening) * creatinine clearance estimated glomerular filtration rate (egfr) \< 90 milliliter per minute (ml/min) (at screening) * participants with gall bladder removal or other relevant surgery of gastrointestinal tract * history of any malignancy * history of epilepsy * ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or excipients * participants who in the investigator's judgment were perceived as having an increased risk of bleeding * positive screen for alcohol or drugs of abuse (at screening and day -1) * positive screen for hepatitis b surface antigen (hbsag), hepatitis c virus antibody (anti-hcv), and human immunodeficiency virus 1 and 2 antibodies (hiv1/hiv2 antibodies) (at screening) * excessive consumption of xanthine-containing food or beverages before study drug administration until collection of last pharmacokinetic (pk) sample in each period (at screening and day -1) * receipt of any prescription or nonprescription medication within 14 days or 5 half-lives, before study drug administration * smoker or former smoker who stopped smoking less than 6 months before the time of the screening visit * intake of grapefruit, seville orange, cranberry or juices of these 3 fruits, or st. john's wort, from 14 days prior to day -1 * inability to communicate or cooperate with the investigator * other factors, which in the opinion of the investigator may interfere with study conduct (at screening and day -1 of first period only) * legal incapacity or limited legal capacity * participants kept in detention * other protocol defined exclusion criteria could apply

Keywords: non-small cell lung cancer (nsclc) p-glycoprotein tepotinib dabigatran etexilate