A phase 1, randomized, crossover trial to assess the effect of itraconazole on the pharmacokinetics of dordaviprone in healthy adults

Concomitant administration of dordaviprone with itraconazole significantly increased dordaviprone exposure confirming CYP3A4 is a major clearance pathway for dordaviprone. While dordaviprone was generally well tolerated when administered as a single 125-mg dose with concomitant itraconazole, dose adjustment in patients receiving 625 mg dordaviprone with strong CYP3A4 inhibitors is warranted.