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A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

NCT03066687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-06-23

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Erdafitinib

Erdafitinib 9 mg (provided as one 4-mg tablet \[G-024\] and one 5-mg tablet \[G-025\]) will be administered orally on Day 1 in each Treatment Period of assigned sequence.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • 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
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2017-05-12
Completion
2017-05-12
FDA Drug
Yes

Countries

  • United States

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 NCT03066687 on ClinicalTrials.gov