A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

Phase 1 Completed 54 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the effect of multiple doses of fluconazole (an inhibitor of cytochrome P450 \[CYP\] 2C9 and CYP3A) and itraconazole (an inhibitor of CYP3A4 and P-glycoprotein \[P-gp\]) on the pharmacokinetics of a single 4-milligram (mg) oral dose of erdafitinib in healthy adult participants.

Timeline

Start: 2017-04-14
Primary completion: 2017-09-01
Completion: 2017-09-01

Publications

Poggesi I, Li LY, Jiao J, Hellemans P, Rasschaert F, de Zwart L, Snoeys J, De Meulder M, Mamidi RNVS, Ouellet D. Effect of Fluconazole and Itraconazole on the Pharmacokinetics of Erdafitinib in Healthy Adults: A Randomized, Open-Label, Drug-Drug Interaction Study. Eur J Drug Metab Pharmacokinet. 2020 Feb;45(1):101-111. doi: 10.1007/s13318-019-00581-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erdafitinib	Small molecule	4 mg	Oral
Subject	Fluconazole	Small molecule	400 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral

Indications

No indication recorded.