An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics - Cmax (sitravatinib)
研究概览
简要总结
An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in
- •Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception
- •Male subjects must agree to use contraception
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions
排除标准
- •History of drug/chemical abuse within 2 years prior to screening.
- •History of alcohol abuse within 12 months prior to screening
- •Positive urine drug screen at screening or check-in or positive alcohol test at check-in.
- •Use of tobacco- or nicotine-containing products or e-cigarettes (with or without nicotine) within 3 months prior to check-in for Period 1; or positive cotinine at screening or check-in.
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to study drug administration on Day 1 of Period
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period
- •Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.
研究组 & 干预措施
Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal)
Dosing in the fasted state followed by fed dosing after high and low fat meals
干预措施: sitravatinib (Drug)
Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal)
Dosing in the fasted state followed by fed dosing after low and high fat meals
干预措施: sitravatinib (Drug)
Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal)
Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal
干预措施: sitravatinib (Drug)
Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state
Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state
干预措施: sitravatinib (Drug)
Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)
Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal)
干预措施: sitravatinib (Drug)
Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state
Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state
干预措施: sitravatinib (Drug)
结局指标
主要结局
Pharmacokinetics - Cmax (sitravatinib)
时间窗: Up to 72 hours after dosing
Maximum observed plasma concentration
Pharmacokinetics - AUC∞ (sitravatinib)
时间窗: Up to 72 hours after dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - AUClast (sitravatinib)
时间窗: Up to 72 hours after dosing
AUC from time zero to the last measured time point
次要结局
- Adverse Events (AEs)(Up to 44 days)