Effect of HM30181A on the Pharmacokinetics of Dabigatran

As HM30181A is an inhibitor of P-gp, it may increase the bioavailability of orally administered drugs which are substrates of P-gp such as dabigatran. The primary objective of this study is to determine the effect of multiple once-daily doses of HM30181A on the single-dose pharmacokinetics of dabigatran. In addition, the study will estimate the duration of the effect on P-gp inhibition by HM30181A on dabigatran exposure by determining the PK of dabigatran at 2 and 4 weeks after the administration of HM30181A. Eligible participants will receive a single oral tablet of dabigatran 75mg and will provide blood samples for analysis for 48 hours post-dosing (Treatment Period 1). After at least a 7 day washout, Treatment Period 2 will start. During Treatment Period 2, participants will receive daily oral doses of a 15mg HM30181A tablet for 3 days (Days 1, 2 and 3). One hour after the third dose they will receive a single oral tablet of dabigatran 75mg. Blood samples will be collected for Days 1-8. On Day 17, they will have another single oral tablet of dabigatran 75mg with blood samples collected for 5 days post-dose. On Day 31 they will have a final dose of a single oral tablet of dabigatran 75mg with blood samples collected for 48 hours post-dose. There will be a followup phone call about 2 weeks after the last blood sample is collected. Safety will be monitored regularly with laboratory tests, aPPT, recording of AEs, ECGs and vital signs. Participants will be resident at the Zenith Clinical Site for dosing (all doses will be under the direct supervision of study site staff) and days when multiple blood samples are required.