ASP8062 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female 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 incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
- •Body Mass Index (BMI) at screening: ≥ 17.6 kg/m^2 and < 26.4 kg/m^2 [BMI = Body weight (kg) ÷ {Body height (m)^2}].
- •Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
- •Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration.
- •Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects.
- •Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.
排除标准
- •Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
- •Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission.
- •Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission (Day -1).
- •Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2).
- •Any deviation from the normal range of routine 12-lead ECG at screening.
- •Subjects with a complication or history of drug allergies.
- •Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission.
- •Subjects with a history of gastrointestinal resection except for appendicitis.
- •Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor.
- •Subjects who received ASP8062 previously.
- •Subject has a relevant history of suicide attempt or suicidal behavior.
研究组 & 干预措施
ASP8062 lower dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
干预措施: ASP8062 (Drug)
ASP8062 middle dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
干预措施: ASP8062 (Drug)
ASP8062 higher dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
干预措施: ASP8062 (Drug)
Placebo
Subjects will receive a single dose of Placebo on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessed by incidence of adverse events
时间窗: Up to Day 38
Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Safety assessed by vital signs: axillary body temperature
时间窗: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Safety assessed by 12-lead electrocardiogram
时间窗: Up to Day 21
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Safety assessed by body weight
时间窗: Up to Day 38
To assess the body weight as a criteria of safety and tolerability variables.
Safety assessed by laboratory tests: Urinalysis
时间窗: Up to Day 38
To assess urinalysis as a criteria of safety and tolerability variables.
Safety assessed by vital signs: supine pulse rate
时间窗: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Orthostatic challenge tests
时间窗: Up to Day 20
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Safety assessed by laboratory tests: Biochemistry
时间窗: Up to Day 38
To assess biochemistry as a criteria of safety and tolerability variables.
Columbia-Suicide Severity Rating Scale
时间窗: Up to Day 20
To assess the suicide risk
Safety assessed by laboratory tests: Hematology
时间窗: Up to Day 38
To assess hematology as a criteria of safety and tolerability variables.
Safety assessed by vital signs: supine blood pressure
时间窗: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
次要结局
- Accumulation Ratio (Rac) of Cmax(From Day 7 to Day 38)
- Rac of AUC(From Day 7 to Day 38)
- PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)(Up to Day 6)
- PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)(Up to Day 6)
- PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)(Up to Day 6)
- PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)(From Day 7 to Day 20)
- Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)(Up to Day 38)
- PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)(Up to Day 6)
- PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)(Up to Day 6)
- PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)(Up to Day 38)
- PK parameter for ASP8062: Terminal elimination half-life (t1/2)(Up to Day 38)
- PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))(Up to Day 6)
- PK parameter for ASP8062: Time of the last measurable concentration (tlast)(Up to Day 38)
- PK parameter for ASP8062: Time to maximum concentration (Tmax)(Up to Day 38)
- PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)(Up to Day 38)
- PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)(From Day 7 to Day 38)
- Peak-Trough Ratio for last dosing in multiple dose part(Day 20 and Day 21)