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.

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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
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article

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

Peter Hellemans, Marc De Meulder, Anna Mitselos, Hui Tian et al.
Clinical Pharmacology in Drug Development
Fibroblast Growth Factor Research
article

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

Peter Hellemans, Marc De Meulder, Anna Mitselos, Hui Tian, Juhui James Jiao, Wei Zhu
article en

Abstract

, 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.

Clinical Pharmacology in Drug DevelopmentVol. 15(5)
Johnson & Johnson (United States) (US), Johnson & Johnson (Brazil) (BR)
Good health and well-being
Openalex Percentile: Top 12%
Fibroblast Growth Factor Research
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