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

Primary Purpose

Hepatic Impairment, Healthy

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Lazertinib

About this trial

This is an interventional basic science trial for Hepatic Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services Kiel GmbH
APEX GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Full Information

NCT ID

NCT05112952

First Posted

November 2, 2021

Last Updated

October 11, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05112952

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

July 11, 2022 (Actual)

Study Completion Date

July 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment, Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: Group 1: Moderate Hepatic Impairment

Arm Type

Experimental

Arm Description

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

Arm Title

Part A: Group 2: Normal Hepatic Function

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lazertinib

Other Intervention Name(s)

JNJ-73841937,, YH25448

Intervention Description

Lazertinib tablet will be administered orally.

Primary Outcome Measure Information:

Title

Plasma Concentrations of Lazertinib

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 49 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Kiel GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

APEX GmbH

City

Munchen

ZIP/Postal Code

81241

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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