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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05112952
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Lazertinib — DRUG
    Lazertinib tablet will be administered orally.

Study Details

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.

Key Dates

Start date
Nov 30, 2021
Status verified
Apr 2025
Primary completion
Jul 11, 2022
Completion
Jul 11, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part A: Group 1: Moderate Hepatic Impairment
    Participants with moderate hepatic impairment will receive a single oral dose of lazertinib.
  • Active Comparator: Part A: Group 2: Normal Hepatic Function
    Participants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib.
  • Experimental: Part B: Group 3 (Optional): Mild Hepatic Impairment
    Participants with mild hepatic impairment will receive a single oral dose of lazertinib.
  • Experimental: Part B: Group 4 (Optional): Severe Hepatic Impairment
    Participants with severe hepatic impairment will receive a single oral dose of lazertinib.

Primary Outcome Measure

Plasma Concentrations of Lazertinib [ Time Frame: Predose up to 312 hour postdose (up to Day 14) ]

Related Studies