A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 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
- Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
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] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 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
- Basic Science
- 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 ages 18 to 50 years
- •Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2
- •Subject is willing to comply with any applicable contraceptive and sperm donation requirements
- •Key Exclusion criteria:
- •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.
- •Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days
排除标准
- 未提供
研究组 & 干预措施
Radiolabeled SPD557
干预措施: Radiolabeled SPD557 (Drug)
结局指标
主要结局
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358
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.
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358
时间窗: Over 240 hours post-dose
Area under the plasma concentration versus time curve from time 0 to infinity. 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.
次要结局
未报告次要终点