Drug Interaction Study Clinical Trial
Official title:
A Phase 1, Open-Label, Drug-Interaction Study to Evaluate the Effect of Clarithromycin, a Potent CYP3A4 Inhibitor, on the Systemic Exposure of Pacritinib in Healthy Subjects
This will be an open-label, single-center, crossover, one-way, drug-interaction study to evaluate the effect of 500 mg clarithromycin BID (dosed to steady state) on the PK of a single 400-mg dose of pacritinib in healthy male and female subjects.
This was a single-center, open-label, one-way crossover, drug-interaction study. On Day 1, subjects received a single oral 400-mg dose of pacritinib. On Day 8 through the morning of Day 12, following a 7-day washout period, 500-mg oral doses of clarithromycin were administered twice daily (BID), 8 to 12 hours apart. It was anticipated that steady-state concentrations of clarithromycin would be achieved by Day 12. On Day 12, a single oral 400-mg dose of pacritinib was co-administered with the final 500-mg dose of clarithromycin. ;
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