NCT04330248

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

An Open-label, Single-sequence, Drug-drug Interaction Study to Evaluate the Effect of Steady-state Carbamazepine on the Single-dose Pharmacokinetics of Erdafitinib Tablets in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-03-31
• Primary completion: 2022-06-14
• Completion: 2022-06-14
• First posted: 2020-04-01
• Last updated: 2023-06-29

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study