Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Safety assessed by Vital signs
研究概览
简要总结
The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight: ≥50.0 kg and <80.0 kg
- •Body mass index BMI: ≥17.6 and <26.4 [BMI= Body weight (kg)/(Height (m))2]
排除标准
- •Subjects who received any study drugs in other clinical trials or post-marketing studies within 120 days before screening
- •Subjects who received or are scheduled to receive medications (including over-the-counter [OTC] drugs) within seven days before the hospital admission day of period
- •Subjects who deviate from the normal range of blood pressure, pulse rate, body temperature and standard 12-lead ECG at screening or the hospital admission day of period 1
- •Subjects who meet any of the criteria for laboratory tests at screening or the hospital admission day of period
- •Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
- •Subjects with a complication of drug allergies
- •Subjects who developed upper gastrointestinal symptoms (e.g., nausea, vomiting, and stomachache) within seven days before the hospital admission day of period 1
- •Subjects with a complication or history of hepatic disease (hepatitis viral and drug-induced liver injury, etc.)
- •Subjects with a complication or history of heart disease (cardiac failure congestive, angina pectoris and arrhythmia requiring treatments, etc.)
- •Subjects with a complication or history of respiratory disease (severe asthma bronchial and bronchitis chronic, etc.) (except for a history of non-severe infantile asthma)
- •Subjects with a complication or history of alimentary disease (severe peptic ulcer, reflux esophagitis, etc.) (except for a history of appendicitis)
- •Subjects with a complication or history of renal disease (acute kidney injury, glomerulonephritis, nephritis interstitial, etc.) (except for a history of calculus)
- •Subjects with a complication or history of cerebrovascular disorder (cerebral infarction, etc.)
- •Subjects with a complication or history of malignant tumor
- •Subjects who have a habit of excessive alcohol drinking or smoking
- •Subjects who previously received administration of ASP8825
研究组 & 干预措施
Fasted dosing preceding group
干预措施: ASP8825 (Drug)
Fed dosing preceding group
干预措施: ASP8825 (Drug)
结局指标
主要结局
Safety assessed by Vital signs
时间窗: Up to 3 days after the each study drug dosing
Supine blood pressure, supine pulse rate and axillary body temperature
PK parameters of gabapentin: AUClast
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Safety assessed by AEs
时间窗: Up to 8 days after the final study drug dosing
AEs: Adverse Events
Pharmacokinetics (PK) parameter of gabapentin: Cmax
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
Cmax: Maximum concentration
Safety assessed by Laboratory tests
时间窗: Up to 3 days after the each study drug dosing
Hematology, blood biochemistry, and urinalysis
Safety assessed by 12-lead ECGs
时间窗: Up to 3 days after the each study drug dosing
ECG: Electrocardiogram
次要结局
- PK parameters of gabapentin tmax(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)
- PK parameters of gabapentin: MRTlast(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)
- PK parameters of gabapentin: kel(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)
- PK parameter of gabapentin: AUCinf(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)
- PK parameters of gabapentin: t1/2(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)
- PK parameters of gabapentin: CL/F(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)
- PK parameters of gabapentin: MRTinf(Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing)