A Phase 1, Open‐Label, Single‐Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an <i>FGFR</i> Inhibitor
, 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.
Authors
- Peter Hellemans
- Marc De Meulder
- Anna Mitselos
- Hui Tian (ORCID: https://orcid.org/0000-0002-8932-3003)
- Juhui James Jiao
- Wei Zhu
Institutions
- Johnson & Johnson (United States) (US)
- Johnson & Johnson (Brazil) (BR)
Publication Details
- Journal
- Clinical Pharmacology in Drug Development
- Published
- 2026-04-30
- DOI
- https://doi.org/10.1002/cpdd.70061
- Primary Topic
- Fibroblast Growth Factor Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00