Single 6 mg erdafitinib dose shows similar pharmacokinetics in mild or moderate hepatic impairment versus healthy controls.

This Phase 1 open-label single-dose study assessed the pharmacokinetics of erdafitinib in participants with hepatic impairment compared to healthy controls. The sample size included 26 participants. The intervention was a single 6 mg oral dose of erdafitinib, with healthy controls serving as the comparator. Follow-up duration was not reported.

Primary outcomes measured included free Cmax, free AUC, and tmax. Free Cmax was 96.07% in mild hepatic impairment and 104.8% in moderate hepatic impairment relative to controls. Free AUC was 95.22% in mild hepatic impairment and 87.51% in moderate hepatic impairment. Median tmax was 3 hours across all groups. Geometric mean ratios were used for effect size. Absolute numbers, p-values, and confidence intervals were not reported.

Safety analysis indicated no new safety signals were noted. Serious adverse events were not reported. Discontinuations were not reported. Single oral doses of erdafitinib were well tolerated across all cohorts. Funding or conflicts were not reported.

The study suggests dose adjustments are not necessary in participants with mild or moderate hepatic impairment receiving oral erdafitinib. Limitations include the open-label design and lack of reported p-values or confidence intervals. Practice relevance is limited to mild or moderate hepatic impairment based on these findings.