A Phase 1, Open-Label, Single-Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an FGFR Inhibitor.

Abstract

Erdafitinib, an oral pan-FGFR inhibitor is extensively metabolized in the liver. This open-label, single-dose, phase 1 study evaluated the pharmacokinetics (PK) of erdafitinib in participants with hepatic impairment versus healthy controls. Overall, 26 participants were enrolled. Following a single 6 mg oral dose, the maximum plasma concentration (C_max) of total erdafitinib was reached at median t_max of 3 h across all groups (participants with mild hepatic impairment, moderate hepatic impairment, and control). The geometric mean ratios for free C_max and free AUC_∞, were 96.07% and 95.22% in participants with mild hepatic impairment compared with controls, respectively. The geometric mean ratios for free C_max and free AUC_∞, were 104.8% and 87.51% in participants with moderate hepatic impairment compared with controls, respectively. Single oral doses of erdafitinib were well tolerated across all cohorts, and no new safety signals were noted. The results demonstrate that dose adjustments are not necessary in participants with mild or moderate hepatic impairment receiving oral erdafitinib.