ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese 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
- Safety assessed by ophthalmological examination
研究概览
简要总结
The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight: ≥50.0 kg and <85.0 kg
- •Body mass index (BMI): ≥17.6 and <26.4 kg/m2
排除标准
- •Subjects with a complication of any diseases
- •Subjects with a history of hepatic disease
- •Subjects with a history of heart disease
- •Subjects with a history of respiratory disease
- •Subjects with a history of alimentary disease
- •Subjects with a history of renal disease
- •Subjects with a history of cerebrovascular disorder
- •Subjects with a history of malignant tumor
- •Subjects with a history of drug allergies or allergies disorders excluding pollinosis
- •Subjects with a history of drug dependency or alcohol dependence syndrome
- •Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
- •Subjects who do not meet any of the criteria for laboratory tests
- •Subjects who received medications within 14 days before the initial dosing.
- •Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
- •Excessive alcohol drinking or smoking habit
- •Subjects who previously received administration of ASP2151 (including placebo)
- •Abnormalities detected on an ophthalmological examination
- •Subjects who deviate from the normal range of standard 12-lead ECG at screening
研究组 & 干预措施
ASP2151 Low dose in non-elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
干预措施: ASP2151 (Drug)
ASP2151 High dose in non-elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
干预措施: ASP2151 (Drug)
ASP2151 Low dose in elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
干预措施: ASP2151 (Drug)
ASP2151 High dose in elderly subjects group
Subjects will receive ASP2151 daily on Days 1 to 7.
干预措施: ASP2151 (Drug)
Placebo in non-elderly subjects group
Subjects will receive matching placebo daily on Days 1 to 7.
干预措施: Placebo (Drug)
Placebo in elderly subjects group
Subjects will receive matching placebo daily on Days 1 to 7.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessed by ophthalmological examination
时间窗: Up to Day 14
Pharmacokinetics of ASP2151 in plasma: CL/F
时间窗: Up to Day 9
CL/F: Apparent total systemic clearance
Pharmacokinetics of ASP2151 in urine: Ae
时间窗: Up to Day 9
Ae: Amount excreted in urine
Safety assessed by Vital sign measurement: axillary body temperature
时间窗: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram for QT assessment
时间窗: Up to Day 14
Pharmacokinetics of ASP2151 in plasma: C24
时间窗: Up to Day 9
C24: Concentration at 24hours after dosing
Pharmacokinetics of ASP2151 in urine: Cumulative Ae
时间窗: Up to Day 9
Pharmacokinetics of ASP2151 in urine: CLR
时间窗: Up to Day 9
CLR: Renal clearance
Safety assessed by laboratory test: urinalysis
时间窗: Up to Day 14
Safety assessed by vital sign measurement: supine pulse rate
时间窗: Up to Day 14
Pharmacokinetics of ASP2151 in plasma: tmax
时间窗: Up to Day 9
tmax: The time after dosing when Cmax occurs
Pharmacokinetics of ASP2151 in urine: Ae%
时间窗: Up to Day 9
Ae%: Percent of ASP2151 amount excreted in urine
Pharmacokinetics of ASP2151 in urine: Cumulative Ae%
时间窗: Up to Day 9
Safety assessed by laboratory test: blood biochemistry
时间窗: Up to Day 14
Safety assessed by vital sign measurement: supine blood pressure
时间窗: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram
时间窗: Up to Day 14
Safety assessed by incidence of adverse events
时间窗: Up to Day 14
Pharmacokinetics of ASP2151 in plasma: t1/2
时间窗: Up to Day 9
t1/2: Apparent terminal elimination half-life
Pharmacokinetics of ASP2151 in plasma: AUCinf
时间窗: Up to Day 9
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Safety assessed by laboratory test: Hematology
时间窗: Up to Day 14
Pharmacokinetics of ASP2151 in plasma: Cmax
时间窗: Up to Day 9
Cmax: Maximum concentration
Pharmacokinetics of ASP2151 in plasma: AUC24
时间窗: Up to Day 9
AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing
次要结局
未报告次要终点