A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants

Inclusion criteria

• Overtly healthy males or females, as determined by medical history, physical examination and vital signs.
• Body mass index (BMI) within the range of 19 to 35 kilograms per meter squared (kg/m²)
• Male participants are not required to adhere to contraceptive requirements and female participants of childbearing potential must agree to be either remain abstinent or stay in a same sex relationship without sexual relationships with males or must agree to use a highly effective method of contraception and who underwent bilateral salpingectomy. The Female participants not of childbearing potential are not required to use contraception.

Exclusion criteria

• Have a positive pregnancy test at screening or Day -1, where applicable
• Are planning to become pregnant during the study or within 1 month of study completion
• Are women who are lactating
• Have known allergies to selpercatinib- or dabigatran-related compounds or any components of the formulation of selpercatinib or dabigatran, or history of significant atopy
• Have a history of allergic reactions to medications or food products
• Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator
• Have known bleeding disorder including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder
• Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF >450 msec on more than 1 ECG obtained during screening only
• Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib
• Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have an average weekly alcohol intake that exceeds 21 units per week (males ≤65 years old) and 14 units per week (females); 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirit(s)
• Are smokers of more than 10 cigarettes or e-cigarettes, or 3 cigars or 3 pipes, per day
• Consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day