NCT00800956已完成1 期
An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible
研究概览
简要总结
The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2
排除标准
- •Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication
研究组 & 干预措施
Single oral dose of [14C]-esreboxetine
Experimental
干预措施: [14C]-esreboxetine (Drug)
结局指标
主要结局
Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible
时间窗: Approx 10 days
Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible
时间窗: Approx 10 days
次要结局
- Clinical safety data(Approx 10 days)
- Pharmacokinetic parameters of plasma esreboxetine metabolites if possible(Approx 10 days)
研究者
研究点 (1)
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