NCT05112952已完成1 期
A Single-Dose, Open-Label, Parallel-Group, Multi-Center Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Lazertinib (JNJ-73841937)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Plasma Concentrations of Lazertinib
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Part A: Group 1: Moderate Hepatic Impairment
Experimental
Participants with moderate hepatic impairment will receive a single oral dose of lazertinib.
干预措施: Lazertinib (Drug)
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.
干预措施: Lazertinib (Drug)
Part B: Group 3 (Optional): Mild Hepatic Impairment
Experimental
Participants with mild hepatic impairment will receive a single oral dose of lazertinib.
干预措施: Lazertinib (Drug)
Part B: Group 4 (Optional): Severe Hepatic Impairment
Experimental
Participants with severe hepatic impairment will receive a single oral dose of lazertinib.
干预措施: Lazertinib (Drug)
结局指标
主要结局
Plasma Concentrations of Lazertinib
时间窗: 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.
次要结局
- Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to 49 days)
研究者
研究点 (2)
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