Pharmacokinetics Clinical Trial
Official title:
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Effect of Oral Doses of SCY-078 (Ibrexafungerp) on the Pharmacokinetics of Dabigatran Administered Orally to Healthy Subjects
This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.
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.
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