drugset
drugset / Trial / NCT03587363

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib

NCT03587363 ↗

Phase 1 Terminated 26 enrolled Janssen Research & Development, LLC
Non-randomizedParallel-groupOpen-labelOther

Summary

The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.

Timeline

Start
2018-12-06
Primary completion
2020-12-22
Completion
2020-12-22

Outcome

Outcome not reported

Stopped (Enrollment): “Mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure. Severe HI cohort enrollment stopped early.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Erdafitinib Small molecule 6 mg Oral

Indications

No indication recorded.