Clinical trial: A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants (NCT04782076)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction