A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety assessed by vital sign measurement: pulse rate
研究概览
简要总结
The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects.
The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.
详细描述
Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum tolerable dose (MTD) if possible.
Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of ASP2151, as determined in part 1 of the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive
排除标准
- •Known or suspected hypersensitivity to ASP2151 or any components of the formulation used
- •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- •Any clinically significant history of genital herpes symptoms and/or herpes zoster symptoms in the 3 months prior to admission to the Clinical Unit
- •Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- •Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: Pulse rate <40 or >90 bpm (beats per minute); mean systolic blood pressure <90 or >140 mmHg (millimeter of mercury); mean diastolic blood pressure <40 or >95 mmHg
- •Regular use of any prescribed or OTC (over the counter) drugs in the 4 weeks prior to admission to the Clinical Unit OR any use of such drugs in the 2 weeks prior to admission to the Clinical Unit
- •Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit
- •History of smoking more than 10 cigarettes per day within 3 months prior to admission to the Clinical Unit
- •History of drinking more than 21 units of alcohol per week within 3 months prior to admission to the Clinical Unit
- •Donation of blood or blood products within 3 months, prior to admission to the Clinical Unit
- •Positive serology test for HBsAg (Hepatitis B surface antigen), HAV IgM (Hepatitis A Virus), anti-HCV (Hepatitis C Virus) or anti-HIV (Human Immunodeficiency Virus) 1 and 2
- •Not willing or able to swallow size 00 capsules
研究组 & 干预措施
Part 1: ASP2151 Single Ascending Dose Group C (Fasting)
Participants will receive single dose of ASP2151 assigned to Group C on day 1
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group A (Fasting)
Participants will receive single dose of ASP2151 assigned to Group A on day 1
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group B (Fasting)
Participants will receive single dose of ASP2151 assigned to Group B on day 1
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group D (Fasting)
Participants will receive single dose of ASP2151 assigned to Group D on day 1
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group E (Fasting)
Participants will receive single dose of ASP2151 assigned to Group E on day 1
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group F (Fasting)
Participants will receive single dose of ASP2151 assigned to Group F on day 1
干预措施: ASP2151 (Drug)
Part 1: Placebo Single Ascending Dose (Fasting)
Participants will receive single dose of matching placebo on day 1
干预措施: Placebo (Drug)
Part 2: ASP2151 (Fasting)
Participants will receive a single dose of ASP2151 under fasted conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2)
干预措施: ASP2151 (Drug)
Part 2: ASP2151 (Fed)
Participants will receive a single dose of ASP2151 under fed conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2)
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group G (Fasting)
Participants will receive single dose of ASP2151 assigned to Group G on day 1
干预措施: ASP2151 (Drug)
Part 1: ASP2151 Single Ascending Dose Group H (Fasting)
Participants will receive single dose of ASP2151 assigned to Group H on day 1
干预措施: ASP2151 (Drug)
结局指标
主要结局
Safety assessed by vital sign measurement: pulse rate
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by physical exam: body weight
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by vital sign measurement: blood pressure
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2 includes systolic and blood diastolic pressure
Safety assessed by physical exam: body mass index (BMI)
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: biochemical
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: urinalysis
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by 12- lead electrocardiogram (ECG)
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: hematological
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by laboratory test: serology
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
Safety assessed by physical exam: height
时间窗: Up to Day 15 of each treatment period
For Part 1 and Part 2
次要结局
- Pharmacokinetics of ASP2151 in plasma: Cmax(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: Vz/F(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: AUC0-inf(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: t1/2(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: tmax(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in urine: Ae0-inf(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in urine: CLr(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: CL/F(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in urine: Aelast(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: AUClast(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in plasma: tlag(Up to 48 hours in each treatment period)
- Pharmacokinetics of ASP2151 in urine: Ae%(Up to 48 hours in each treatment period)