A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
- Registration Number
- NCT05112952
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: Group 4 (Optional): Severe Hepatic Impairment Lazertinib Participants with severe hepatic impairment will receive a single oral dose of lazertinib. Part A: Group 2: Normal Hepatic Function Lazertinib Participants with normal hepatic function who qualify for the control group will receive a single oral dose of lazertinib. Part A: Group 1: Moderate Hepatic Impairment Lazertinib Participants with moderate hepatic impairment will receive a single oral dose of lazertinib. Part B: Group 3 (Optional): Mild Hepatic Impairment Lazertinib Participants with mild hepatic impairment will receive a single oral dose of lazertinib.
- Primary Outcome Measures
Name Time Method Plasma Concentrations of Lazertinib Predose up to 312 hour postdose (up to Day 14) 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
Name Time Method Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Up to 49 days 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.
Trial Locations
- Locations (2)
CRS Clinical Research Services Kiel GmbH
🇩🇪Kiel, Germany
APEX GmbH
🇩🇪Munchen, Germany