A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib (JNJ-73841937)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
研究概览
简要总结
The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history (at screening only), vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site in Intervention Period 1
- •Body weight not less than 50.0 kilograms (kgs) and body mass index (BMI, weight/height^2) within the range 19.0-30.0 kg/m^2 (inclusive) at screening
- •All female participants must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-HCG) test at screening and a negative urine pregnancy test on Day -1 of Intervention Period 1
- •A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study intervention
- •Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and interstitial lung disease, diabetes mellitus (with the exception of history of gestational diabetes), hepatic insufficiency, inflammation bowel disease/Crohn's disease, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs
- •History of malignancy within 5 years before screening
- •Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, ibuprofen, and stable hormone replacement therapy (in postmenopausal female participants only) within 14 days before the first dose of study intervention is scheduled until completion of the study
- •History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
研究组 & 干预措施
Part 1: Sequence BA
Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 2.
干预措施: Lazertinib (Drug)
Part 2: Sequence DC
Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention C (lazertinib reference formulation) on Day 1 of intervention period 2.
干预措施: Lazertinib (Drug)
Part 2: Sequence CD
Participants will receive Intervention C (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention period 2.
干预措施: Lazertinib (Drug)
Part 1: Sequence AB
Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention period 1. After washout period of 14 to 21 days, participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention period 2.
干预措施: Lazertinib (Drug)
结局指标
主要结局
Part 1: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
时间窗: Pre dose up to 168 hours post dose on Day 1
Cmax is defined as maximum observed plasma concentration of lazertinib.
Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 72h (AUC[0-72h]) of Lazertinib
时间窗: Pre dose up to 72 hours post dose on Day 1
AUC(0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.
Part 2: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
时间窗: Pre dose up to 168 hours post dose on Day 1
Cmax is defined as maximum observed plasma concentration of lazertinib.
Part 1: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib
时间窗: Pre dose up to 72 hours post dose on Day 1
AUC(0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.
次要结局
- Number of Participants With Change From Baseline in Clinical Laboratory Test Values(Up to 8 Weeks)
- Number of Participants With Change From Baseline in Physical Examination(Up to 8 Weeks)
- Number of Participants With Adverse Events (AEs)(Up to 8 Weeks)
- Number of Participants With Serious Adverse Events (SAEs)(Up to 8 Weeks)
- Number of Participants With AEs by Severity(Up to 8 Weeks)
- Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)(Up to 8 Weeks)
- Number of Participants With Change From Baseline in Vital Signs(Up to 8 Weeks)