Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
The two‐period crossover study will consist of two treatments administered in random order. Treatments will be separated by a minimum of 10 day wash‐out (between last dose in the first period and first dose in the subsequent period). Healthy male and female subjects will will be enrolled to assess the effects on a single dose of dabigatran mesylate (DAB). Subjects will be screened within 4 weeks prior to dosing and randomized to a treatment sequence (AB or BA) in a crossover fashion. Treatment A: Single oral 150mg dose of DAB. Treatment B: Twice daily (BID), every 12 hours (Q12H) oral doses of SCY‐078 750mg on Day and Day 2; and single oral AM doses of SCY‐078 750mg on Day 3 and Day. On Day 3, a single 150mg dose of DAB will be administered 1 hour after the AM dose of SCY‐078. Subjects will fast overnight after being admitted to the clinic on Day ‐1 and will remain in the clinic until the final procedures are complete. Twenty eight male and female subjects between 18 and 55 years (inclusive) will be enrolled into the study. Subjects who discontinue may be replaced.
Epistemonikos ID: 8f9c1b75b7d81ad302d792d71cd63f9bb1b98bc7
First added on: May 22, 2024