NCT02805374已完成1 期
ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf
研究概览
简要总结
The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.
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
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight: ≥50.0 kg and <80.0 kg
- •Body-mass index : ≥17.6 and <26.4 kg/m2
- •Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug.
- •Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug.
排除标准
- •Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1
- •Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of Period 1
- •Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1
- •Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1
- •Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period
- •Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study.
- •Concurrent or previous drug allergies.
- •Development of (an) upper gastrointestinal symptom(s) within seven days before the hospital admission day of Period
- •Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
- •A history of digestive tract excision.
- •Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311(FG-2216) or erythropoietin products.
- •Excessive alcohol or smoking habit.
研究组 & 干预措施
ASP1517 fasting then fed
Experimental
Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2.
干预措施: ASP1517 (Drug)
ASP1517 fed then fasting
Experimental
Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2.
干预措施: ASP1517 (Drug)
结局指标
主要结局
Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf
时间窗: Up to Day 4 of each treatment period
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of ASP1517 in Plasma: Cmax
时间窗: Up to Day 4 of each treatment period
Cmax: Maximum concentration
次要结局
- PK parameter of ASP1517 in Plasma: AUClast(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: CL/F(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: λz(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: MRTinf(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: t1/2(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: tmax(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: tlag(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Plasma: Vz/F(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Urine: Ae(Up to Day 4 of each treatment period)
- PK parameter of ASP1517 in Urine: CLR(Up to Day 4 of each treatment period)
- Safety assessed by adverse events(Up to Day 9 of Period 2)
- Number of participants with abnormal vital signs and/or adverse events during treatment period(Up to Day 9 of Period 2)
- Number of participants with abnormal laboratory values and/or adverse events during treatment period(Up to Day 9 of Period 2)
- Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period(Up to Day 9 of Period 2)
研究者
研究点 (1)
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