A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Prucalopride Succinate Following a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate
研究概览
简要总结
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate or its break down products are excreted by analysing blood, faeces and urine samples collected during 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged between 18 and 50 years, inclusive
- •Body mass index (BMI) of ≥18 and ≤30 kg/m2
- •No more than 2 bowel movements per day or fewer than 3 bowel movement per week
- •Provision of signed and dated, written informed consent prior to any study specific procedures
排除标准
- •Have participated in a [14C]-study within the last 6 months.
- •Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
- •Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
研究组 & 干预措施
Radiolabeled Prucalopride Succinate
干预措施: Radiolabeled Prucalopride Succinate (Drug)
结局指标
主要结局
Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
The rate at which a drug is removed from the body.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
The time it takes for the blood plasma concentration of a substance to halve.
Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
The distribution of a medication between plasma and the rest of the body.
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate
时间窗: 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate
时间窗: Over 240 hours post-dose
次要结局
未报告次要终点