NCT05244759已完成1 期
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937 in Healthy Male Subjects After Oral Dosing
Bellus Health Inc. - a GSK company1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年8月25日最近更新:
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
- 试验地点
- 1
- 主要终点
- Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937
研究概览
简要总结
This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of [14C]-BLU-5937.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
排除标准
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,as judged by the investigator
研究组 & 干预措施
Arm 1
Experimental
Single oral dose of [14C]-BLU-5937
干预措施: [14C]-BLU-5937 (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937
时间窗: 168 hour
Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in blood, urine and faeces samples.
次要结局
未报告次要终点
研究者
研究点 (1)
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