Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate

Phase I, Open-label, Single Sequence, Two-Period Study to Evaluate the Effect of Tepotinib on P-gp by Investigating the PK of the P-gp Probe Substrate Dabigatran Etexilate in Healthy Subjects

This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.

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 mmHg, diastolic blood pressure (DBP) > 90 or < 50 mmHg, and pulse rate > 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