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

NCT03135106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-02-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • Belgium

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 NCT03135106 on ClinicalTrials.gov