The Effect of Food on the Bioavailability of Merestinib in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
研究概览
简要总结
The purpose of this study is to evaluate the effect of food on merestinib (standard meal and high-fat meal) compared to the fasted state. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In addition, the tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last approximately 28 days. Screening is required within 28 days prior to the start of the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy sterile male and female participants
- •Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- •Are willing and able to eat the protocol specified high-fat breakfast
排除标准
- •Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Have donated blood of more than 500 milliliters (mL) within the last month
- •Cannot stop taking over-the-counter (OTC) or prescription medications that alter gastric pH, at least 14 days prior to first dosing
- •Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product
研究组 & 干预措施
Merestinib Fasted
Single dose of merestinib administered in fasted state in one of three periods
干预措施: Merestinib (Drug)
Merestinib Standard Meal
Single dose of merestinib administered with a standard meal in one of three periods
干预措施: Merestinib (Drug)
Merestinib High-Fat Meal
Single dose of merestinib administered with a high-fat meal in one of three periods
干预措施: Merestinib (Drug)
结局指标
主要结局
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
时间窗: Predose through 120 hours after administration of study drug
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State
时间窗: Predose through 120 hours after administration of study drug
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State
时间窗: Predose through 120 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State
时间窗: Predose through 120 hours after administration of study drug
次要结局
- Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State(Predose through 120 hours after administration of study drug)
- Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State(Predose through 120 hours after administration of study drug)
- Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State(Predose through 120 hours after administration of study drug)
- Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State(Predose through 120 hours after administration of study drug)