Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Loxo Oncology, Inc.
With
Eli Lilly and Company
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
