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

NCT05112952 | Completed Phase 1

• 3 other identifiers: CR1090222021-001950-7173841937NSC1007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Plasma Concentrations of Lazertinib

  Plasma concentrations of lazertinib will be analyzed using a validated, specific, and sensitive method to assess the effect of hepatic impairment on the pharmacokinetic of lazertinib.

  Predose up to 312 hour postdose (up to Day 14)

Secondary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to 49 days

Study Arms (4)

Part A: Group 1: Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single oral dose of lazertinib.

Drug: Lazertinib

Part A: Group 2: Normal Hepatic Function

ACTIVE COMPARATOR

Participants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib.

Drug: Lazertinib

Part B: Group 3 (Optional): Mild Hepatic Impairment

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single oral dose of lazertinib.

Drug: Lazertinib

Part B: Group 4 (Optional): Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive a single oral dose of lazertinib.

Drug: Lazertinib

Interventions

Lazertinib DRUG

Lazertinib tablet will be administered orally.

Also known as: JNJ-73841937,, YH25448

Part A: Group 1: Moderate Hepatic Impairment; Part A: Group 2: Normal Hepatic Function; Part B: Group 3 (Optional): Mild Hepatic Impairment; Part B: Group 4 (Optional): Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants:
• Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
• Willing and able to adhere to the prohibitions and restrictions specified in this protocol
• If a woman, must not be of childbearing potential: postmenopausal (amenorrhea for at least 12 months and a serum follicle stimulating hormone within postmenopausal range); or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation procedure)
• Healthy Participants with normal hepatic function:
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic for participants less than or equal to (\<=) 60 years old and between 90 and 150 mmHg for participants greater than (\>) 60 years old, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted per visit
• Pharmacogenomics: Healthy participants must have matching glutathione S-transferase Mu 1 (GSTM1) genotype (null or non-null GSTM1 genotype) to individual hepatic impairment group participants
• Participants with hepatic impairment:
• A 12-lead electrocardiogram (ECG) consistent with adequate cardiac conduction and function as per judgement by the investigator, including: a) Sinus rhythm; b) Heart rate between 50 and 100 beats per minute (extremes included); c) QTc interval \<= 480 milliseconds (ms) (corrected cf. Fridericia; QTcF)
• Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study

You may not qualify if:

• All Participants:
• Participant has known allergies, hypersensitivity, or intolerance to Lazertinib or its excipients
• Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc.), with the exception of hepatic impairment
• Active gall bladder or biliary tract disease (example, acute cholecystitis, symptomatic cholelithiasis)
• Participant tests positive for human immunodeficiency virus (HIV)-1 or HIV-2 at screening
• Participant has a lack of adequate venous access

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Interventions

lazertinib

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 9, 2021
• Study Start: November 30, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)