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

NCT03587363 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Erdafitinib

Participants will receive 6 mg (2\*3 mg tablet) erdafitinib as a single oral dose on Day 1. Participants in Cohort 4 may receive a lower dose if warranted by preliminary safety and PK data from Cohorts 2 and 3.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587363 on ClinicalTrials.gov