NCT03135106

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

A Randomized, Open-Label, Parallel Group, Drug-drug Interaction Study to Evaluate the Effect of Fluconazole and Itraconazole on the Pharmacokinetics of Erdafitinib in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Erdafitinib	A single 4-mg of erdafitinib tablet will be administered on Day 1 in Treatment A and on Day 5 in Treatment B and C.
DRUG	Fluconazole	A 400-mg fluconazole orally (4\*100 mg capsules) will be administered from Day 1 to Day 11.
DRUG	Itraconazole	A 200-mg itraconazole orally (2\*100 mg capsules) will be administered from Day 1 to Day 11.

Timeline

• Start date: 2017-04-14
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2017-05-01
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium