NCT00906191已完成1 期
An Open-Label, Single-Dose, Nonrandomized Study Of The Mass Balance And Metabolic Disposition Of Orally Administered 14C-Labeled SAM-531 In Healthy Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 6 人开始时间: 2009年5月最近更新:
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
- 入组人数
- 6
- 主要终点
- Radioactivity measurements in blood, urine and feces and pharmacokinetic parameters (Cmax, AUC, terminal elimination half life, total clearance and volume of distribution in the plasma ; urine clearance ; metabolite profiling in plasma, urine and feces.)
研究概览
简要总结
The objective of this study is to investigate how quickly and to what extent the 14-Carbon labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is radioactive, this enables the compound to be traced in blood, urine and feces.
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
- Health Services Research
- 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
- •Men aged 18 to 50 years inclusive at screening
- •Healthy as determined by the investigator on the basis of screening evaluations
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
研究组 & 干预措施
1
Experimental
Single oral dose
干预措施: SAM-531 (Drug)
结局指标
主要结局
Radioactivity measurements in blood, urine and feces and pharmacokinetic parameters (Cmax, AUC, terminal elimination half life, total clearance and volume of distribution in the plasma ; urine clearance ; metabolite profiling in plasma, urine and feces.)
时间窗: 15 days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLCCarcinoma, Non-Small-Cell LungNCT03001609Hangzhou ACEA Pharmaceutical Research Co., Ltd.7
已完成
1 期
A Study in Healthy Volunteers to Investigate How Much Test Medicine [14C]-Uproleselan is Taken up by the Body When Administered Directly Into the Vein (IV)Healthy SubjectsNCT03606447GlycoMimetics Incorporated5
已完成
1 期
Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and MetforminHealthy VolunteersNCT04231435Celgene24
已完成
1 期
A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The BodyHealthyNCT02110342Pfizer6
尚未招募
1 期
Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisNCT02478450Q Therapeutics, Inc.30