A Randomized, Open Label, Two-sequence, Two-period Crossover Study to Assess the Food Effect on the Pharmacokinetics of Single-Dose Administration of the To-Be-Marketed Formulation of K-877 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax of K-877
研究概览
简要总结
Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject provides written informed consent before any study-specific evaluation is performed;
- •Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at screening;
- •Subject has a BMI of 18 to 30 kg/m2, inclusive, at screening
- •Subject meets all inclusion criteria outlined in the clinical study protocol
排除标准
- •Subject is a woman who is pregnant or breastfeeding;
- •Subject has clinically significant abnormalities in the screening or check-in assessments;
- •Subject has received an investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug
- •Subject does not meet any other exclusion criteria outlined in clinical study protocol.
研究组 & 干预措施
Fasted-Fed
Single dose of K-877 administered in a fasted condition on Day 1 (Treatment Period 1) and postprandially on Day 4 (Treatment Period 2)
干预措施: K-877 (Drug)
Fed-Fasted
Single dose of K-877 administered postprandially on Day 1 (Treatment Period 1) and in a fasted condition on Day 4 (Treatment Period 2)
干预措施: K-877 (Drug)
结局指标
主要结局
Cmax of K-877
时间窗: pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4
Observed maximum plasma concentration (Cmax)
AUC0-t of K-877
时间窗: pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
AUC0-inf of K-877
时间窗: pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
次要结局
- Tmax of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)
- MRT0-t of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)
- MRT0-inf of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)
- t1/2 of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)
- Kel of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)
- CL/F of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)
- Vd/F of K-877(pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4)