An Open Label Study to Evaluate the Pharmacokinetics of ASP1707 After a Single Oral Dose of 14C-labeled ASP1707 in Healthy 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
- Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)
研究概览
简要总结
Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are collected until at least 144 hours after dosing.
详细描述
Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if sufficient recovery of administered radioactivity is achieved, or the total excretion (urine + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour intervals. If these conditions are not met, the residential period may be prolonged for a maximum of 3 days. If after this time one of the conditions is still not met, subjects are requested to continue collecting their urine and/or feces at home for another 2 days. If after these additional 2 days one of the conditions is still not met, the condition of recovery of radioactivity is disregarded. Therefore only the total excretion condition is to be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If the excretion condition is still not met after this time, no further samples are collected and the subject is discharged from the study.
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
- •Subjects must be surgically sterilized and use condoms or must practice an effective contraceptive method to prevent pregnancies.
- •Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m
- •Regular defecation pattern (minimum once per day).
排除标准
- •Any of the liver function tests above the upper limit of normal.
- •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.
- •Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit.
- •History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day 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 Hepatitis B Surface Antigen (HBsAg), anti Hepatitis A Virus (HAV) Immunoglobulin M (IgM), anti Hepatitis C Virus (HCV) or anti Human Immunodeficiency Virus (HIV) 1+2.
研究组 & 干预措施
1: ASP1707
干预措施: 14C-labeled ASP1707 (Drug)
结局指标
主要结局
Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by CL/F
时间窗: Day -1 until at least Day 7
Radioactivity in whole blood measured by Area under the plasma concentration - time curve to the last quantifiable concentration (AUClast)
时间窗: Day -1 until at least Day 7
Radioactivity in whole blood measured by Maximum concentration (Cmax)
时间窗: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent total body clearance (CL/F)
时间窗: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by AUCinf
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by AUClast
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by Cmax
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by tmax
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by t1/2
时间窗: Day -1 until at least Day 7
Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)
时间窗: Day -1 until at least Day 7
Radioactivity in whole blood measured by Time to Attain Cmax (tmax)
时间窗: Day -1 until at least Day 7
Radioactivity in plasma measured by Vz/F
时间窗: Day -1 until at least Day 7
Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)
时间窗: Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in urine
时间窗: Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in feces
时间窗: Day -1 until at least Day 7
Total cumulative excretion of radioactivity in urine and feces
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by AUCinf
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by AUClast
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by Cmax
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by tmax
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by t1/2
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by CL/F
时间窗: Day -1 until at least Day 7
ASP1707 in plasma measured by Vz/F
时间窗: Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)
时间窗: Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)
时间窗: Day -1 until at least Day 7
ASP1707 in urine measured by Renal Clearance (CLR)
时间窗: Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)
时间窗: Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)
时间窗: Day -1 until at least Day 7
次要结局
- Profiling of metabolites in plasma, urine and feces(Day -1 until at least Day 7)
- Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination(Screening to ESV (up to Day 40))