Clinical development of KDFX
DST-0509 was tested in 2 phase I studies, Study 101 and 102. Study 101, a single dose study in healthy volunteers, demonstrated improvements in the bioavailability of DST-0509 compared to Jadenu® at a dose of 14 mg/kg. Furthermore, DST-0509 is the first deferasirox formulation to show no differences in total absorption between high-fat fed and fasted states.
Study 102 was a randomized, single dose, 3-period, 3-sequence crossover, oral bioavailability study of DST-0509 compared to Exjade® and Jadenu® in fasted healthy volunteers at higher doses (25 – 33 mg/kg). The results showed less variability in Cmax and AUC with DST-0509 versus Exjade®, and meaningfully enhanced absorption versus Exjade® and Jadenu®.