A Phase 1, Open-label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 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
- •All female participants must have a negative highly sensitive serum Beta-human chorionic gonadotropin (Beta-HCG) at screening and 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 informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •Female participants must be postmenopausal or surgically sterile
排除标准
- •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
- •Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients
- •Participant has a history of clinically significant allergies
- •Had major surgery, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from the surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study intervention administration
研究组 & 干预措施
Intervention Sequence: ADBC
Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention Period 1, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention C (lazertinib test formulation) on Day 1 of Intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
干预措施: Lazertinib (Drug)
Intervention Sequence: BACD
Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 2, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
干预措施: Lazertinib (Drug)
Intervention Sequence: CBDA
Participants will receive intervention C (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
干预措施: Lazertinib (Drug)
Intervention Sequence: DCAB
Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 3 followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
干预措施: Lazertinib (Drug)
结局指标
主要结局
Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
时间窗: Pre dose up to 168 hours post dose
Cmax is defined as maximum observed plasma concentration.
Interventions A, B and C: 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 168 hours post dose
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 Vital Signs(Up to 14 weeks)
- Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib(Pre dose up to 168 hours post dose)
- Number of Participants With Change From Baseline in Clinical Laboratory Test Values(Up to 14 weeks)
- Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)(Up to 14 weeks)
- Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib(Pre dose up to 168 hours post dose)
- Number of Participants With Serious Adverse Events (SAEs)(Up to 14 weeks)
- Number of Participants With Change From Baseline in Physical Examination(Up to 14 weeks)
- Number of Participants With Adverse Events (AEs)(Up to 14 weeks)
- Number of Participants With AEs by Severity(Up to 14 weeks)