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.
Name: DAB
Name: SCY-078 plus DAB
Description: AUC0-48 of DAB when taken with SCY-078
Measure: Pharmacokinetics of DAB administered with SCY-078, AUC Time: 17 daysDescription: Cmax DAB when taken with SCY-078.
Measure: Pharmacokinetics of DAB administered with SCY-078, Cmax Time: 17 daysDescription: Tmax of DAB when taken with SCY-078.
Measure: Pharmacokinetics of DAB administered with SCY-078, Tmax Time: 17 daysDescription: Half Life of DAB when taken with SCY-078.
Measure: Pharmacokinetics of DAB administered with SCY-078, Half Life Time: 17 DaysDescription: Incidence of treatment-related adverse events (AE) and discontinuations due to (AEs)
Measure: Safety and tolerability of oral dosing of combination of DAB with SCY-078 Time: 7 weeksAllocation: Randomized
Crossover Assignment
There is one SNP
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. --- Q12H ---