Clinical trial NCT05112952: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Plasma Concentrations of Lazertinib
timeFrame: Predose up to 312 hour postdose (up to Day 14)
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 49 days
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
city: Munchen
country: Germany
facility: APEX GmbH
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: