An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total radioactivity in plasma
研究概览
简要总结
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.
详细描述
This is an open-label, one-period, single-dose study with 14C labeled ASP3652.
Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.
On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.
The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is white and of Caucasian origin.
- •Regular defecation pattern (minimum once per day).
- •Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
排除标准
- •Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- •Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
- •Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
研究组 & 干预措施
14C labeled ASP3652
干预措施: ASP3652 (Drug)
结局指标
主要结局
Total radioactivity in plasma
时间窗: Days 1 to 6 and up to Day 9
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
Total radioactivity in whole blood
时间窗: Days 1 to 6 and up to Day 9
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)
Radioactivity ratio of plasma / blood
时间窗: Days 1 to 6 and up to Day 9
ratio concentrations per time point and AUC
Radioactivity excretion in urine
时间窗: Urine: Days 1-6 and up to Day 25
excretion rate and cumulative excretion
Radioactivity excretion in feces
时间窗: Days 1-6 and up to Day 25
excretion rate and cumulative excretion
Radioactivity excretion in urine and feces
时间窗: Urine: Days 1-6 and up to Day 25
excretion rate and cumulative excretion
ASP3652 in plasma
时间窗: Days 1 to 6 and up to Day 9
AUCinf, AUClast, Cmax, tmax, t1/2, apparent clearance after oral administration at steady state (CL/F), volume of terminal phase distribution at steady state (Vz/F)
ASP3652 in urine
时间窗: Days 1-6 and up to Day 25
cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf), cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast), renal clearance of the drug from plasma (CLR), percentage of unchanged drug excreted into the urine from time zero to infinity after single dose % of dose excreted (Aeinf%), percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
Ratio ASP3652 to 14C-radioactivity for AUCinf
时间窗: Days 1 to 6 and up to Day 9
area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf)
次要结局
- Safety and tolerability after a single dose(Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge))