A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) profiles of avatrombopag
研究概览
简要总结
This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will be used to assess the fed condition.
详细描述
The study will comprise a Prerandomization Phase and a Randomization Phase. The Prerandomization Phase will include 2 periods, Screening and Baseline 1. The Screening Period will be up to 3 weeks (21 days) in duration. The Randomization Phase will consist of 5 single-dose treatment periods, of which 3 will include administration of avatrombopag in the fed condition and 2 will include administration of avatrombopag in the fasted condition. Each treatment period will be separated by a wash out interval of at least 28 days. Before each treatment period, subjects will complete a baseline period (Baseline Periods 2, 3, 4, and 5), during which baseline assessments will be collected. A Final Visit will occur 28 days (+/- 1 day) after dosing in Treatment Period 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
avatrombopag
Each subject will receive a single administration during each of the 5 treatment periods as follows: 40 and 60 mg in the fed and fasted state, and 20 mg in the fed state. Subjects will be randomized to one of four dosing sequences.
干预措施: avatrombopag (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profiles of avatrombopag
时间窗: Up to 23 Weeks
The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2.
次要结局
- Pharmacodynamic (PD) profiles of avatrombopag(Up to 23 Weeks)
- Comparison of PK and PD for avatrombopag(Up to 23 Weeks)
- Adverse events (AEs ) as a measure of safety and tolerability(Up to 23 Weeks)
- Laboratory assessments as a measure of safety and tolerability(Up to 23 Weeks)
- Vital signs as a measure of safety and tolerability(Up to 23 Weeks)
- Electrocardiogram (ECG) as a measure of safety and tolerability(Up to 23 Weeks)