NCT05112952

A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)

A Single-Dose, Open-Label, Parallel-Group, Multi-Center Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Lazertinib (JNJ-73841937)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Lazertinib	Lazertinib tablet will be administered orally.

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-07-11
• Completion: 2022-07-11
• First posted: 2021-11-09
• Last updated: 2025-04-27

Locations

2 sites across 1 country: Germany