A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma Concentration of Probe Substrates (Midazolam, Rosuvastatin, and Metformin) Co-administered with Lazertinib (Day 13) as Test Versus Plasma Concentration of Probe Substrates Administered Alone (Day 1) as Reference
研究概览
简要总结
The purpose of this study is to evaluate the effect of steady-state concentrations of lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam, rosuvastatin, and metformin) in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 medical history at screening only, and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study center
- •Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study center.
- •A woman who is considered surgically sterile but not postmenopausal, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Study Day
- •(exemptions: pregnancy test not required in female participants with prior hysterectomy or prior bilateral oophorectomy)
- •Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator
- •Non-smoker or not using tobacco containing products for at least 6 months before first study drug administration and test negative for cotinine at screening and Study Day 1
排除标准
- •History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor is considered cured with minimal risk of recurrence)
- •History of suspected or confirmed coronavirus disease 2019 within 4 weeks before intake of study drug, or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at admission to the study site
- •Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients or probe substrates
- •Taken any disallowed therapies, concomitant therapy before the planned first dose of study drug
- •Had major surgery, (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from 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 drug administration
研究组 & 干预措施
Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin
Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13.
干预措施: Lazertinib (Drug)
Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin
Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13.
干预措施: Midazolam (Drug)
Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin
Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13.
干预措施: Rosuvastatin (Drug)
Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin
Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13.
干预措施: Metformin (Drug)
结局指标
主要结局
Plasma Concentration of Probe Substrates (Midazolam, Rosuvastatin, and Metformin) Co-administered with Lazertinib (Day 13) as Test Versus Plasma Concentration of Probe Substrates Administered Alone (Day 1) as Reference
时间窗: Predose up to 12 hours postdose (Days 1 and 13)
Plasma samples will be analyzed to determine concentrations of midazolam and its metabolite 1-OH-midazolam, rosuvastatin, metformin, or lazertinib using a validated, specific, and sensitive method on Day 1 versus Day 13 as a part of drug-drug interaction (DDI) assessment.
次要结局
- Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)(Up to 28 days)
- Number of Participants with Adverse Events (AEs)(Up to 56 days)
- Number of Participants with Clinically Significant Changes in Laboratory Test Results(Up to 28 days)
- Plasma Concentrations of Lazertinib at steady-state(Predose on Day 7, 9, 11, 13, and 14)
- Plasma Concentrations of Lazertinib Following Repeat Dosing for 10 Days(Day 14, 15, 16, 17, 21, and 28)
- Number of Participants with AEs by Severity(Up to 56 days)
- Number of Participants with Clinically Significant Abnormalities in Vital Signs(Up to 28 days)
- Number of Participants with Clinically Significant Abnormalities in Physical Examination(Up to 28 days)