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A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants

NCT04330248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-06-29

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the effect of multiple doses of carbamazepine (a strong inducer of cytochrome P450 \[CYP\]3A4 and a weak inducer of CYP2C9) on the pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Erdafitinib

Participants will receive single oral dose of erdafitinib tablets on Day 1 in Period 1 and on Day 28 in Period 2.

DRUG

Carbamazepine

Participants will receive an oral dose of carbamazepine tablets from Day 15 to 35 in Period 2.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2022-06-14
Completion
2022-06-14
FDA Drug
Yes

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 NCT04330248 on ClinicalTrials.gov