A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-NS-580 Following a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma
研究概览
简要总结
The purpose of this study was to determine the absorption, metabolism, and excretion of radioactivity and to characterize and determine, where possible, the metabolites present in plasma, urine, and faeces in healthy male subjects following a single oral administration of [14C]-NS-580.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males of any race, between 35 and 60 years of age, inclusive.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •History of a minimum of 1 bowel movement per day.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
研究组 & 干预措施
Administration of [14C] NS-580
干预措施: [14C] NS-580 (Drug)
结局指标
主要结局
Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma
时间窗: Pre-dose up to 28 days post-dose
AUC0-inf of NS-580 in plasma
AUC0-inf of [14C] NS-580 in plasma and whole blood for Total Radioactivity
时间窗: Pre-dose up to 56 days post-dose
AUC0-inf of \[14C\] NS-580 in plasma and whole blood
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
时间窗: Pre-dose up to 28 days post-dose
AUC0-tlast of NS-580 in plasma
AUC0-tlast of [14C] NS-580 in plasma and whole blood for Total Radioactivity
时间窗: Pre-dose up to 56 days post-dose
AUC0-tlast of \[14C\] NS-580 in plasma and whole blood
Maximum observed concentration (Cmax) of NS-580
时间窗: Pre-dose up to 28 days post-dose
Cmax of NS-580 in plasma
Cmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity
时间窗: Pre-dose up to 56 days post-dose
Cmax of \[14C\] NS-580 in plasma and whole blood
Time of the maximum observed concentration (Tmax) of NS-580
时间窗: Pre-dose up to 28 days post-dose
Tmax of NS-580 in plasma
Tmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity
时间窗: Pre-dose up to 56 days post-dose
Tmax of \[14C\] NS-580 in plasma and whole blood
Apparent terminal elimination half-life (t1/2) of NS-580
时间窗: Pre-dose up to 28 days post-dose
t1/2 of NS-580 in plasma
t1/2 of [14C] NS-580 in plasma and whole blood for Total Radioactivity
时间窗: Pre-dose up to 56 days post-dose
t1/2 of \[14C\] NS-580 in plasma and whole blood
Renal clearance (CLR) of NS-580
时间窗: Pre-dose up to 28 days post-dose
CLR of NS-580 in plasma
Amount of dose administered urine recovered (Aeu) of NS-580
时间窗: Pre-dose up to 56 days post-dose
Aeu of NS-580
Percentage of dose administered urine recovered (feu) of NS-580
时间窗: Pre-dose up to 56 days post-dose
feu of NS-580
Total radioactivity recovery
时间窗: Pre-dose up to 56 days post-dose
Total radioactivity recovery in urine and faeces
次要结局
- Proportions of NS-580 major metabolites(Pre-dose up to 56 days post-dose)
- Incidence and severity of AEs(Pre-dose up to 56 days post-dose)