The main purpose of this study is to determine the effect of selpercatinib on the levels of dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Administered orally.
Administered orally.
Covance Clinical Research Inc
Daytona Beach, Florida, United States
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran
PK: Cmax of Dabigatran
Time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran
PK: AUC(0-inf) of Dabigatran
Time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: Cmax of Selpercatinib
PK: Cmax of Selpercatinib
Time frame: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: AUC(0-inf) of Selpercatinib
PK: AUC(0-inf) of Selpercatinib
Time frame: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib
Time frame: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
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