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

NCT ID: NCT05112952

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-07-11

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part A: Group 1: Moderate Hepatic Impairment

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

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib tablet will be administered orally.

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.

Group Type: ACTIVE_COMPARATOR

Lazertinib

Intervention Type: DRUG

Lazertinib tablet will be administered orally.

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

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

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib tablet will be administered orally.

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

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

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Lazertinib tablet will be administered orally.

Interventions

Lazertinib

Lazertinib tablet will be administered orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-73841937,; YH25448

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

APEX GmbH

München, , Germany

Countries

Germany

Other Identifiers

2021-001950-71

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

73841937NSC1007

Identifier Type: OTHER

Identifier Source: secondary_id

CR109022

Identifier Type: -

Identifier Source: org_study_id