An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cumulative amount of total radioactivity excreted (CumAe)
研究概览
简要总结
The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019
详细描述
This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Aged 30 to 65 years inclusive at the time of signing informed consent
排除标准
- •Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly gastrointestinal (GI) disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome, neurological or psychiatric disorder, or clinically significant dermatological disorder
- •History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
研究组 & 干预措施
[14C]GRT6019
Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h.
干预措施: [14C]GRT6019 (Drug)
结局指标
主要结局
Cumulative amount of total radioactivity excreted (CumAe)
时间窗: Day -1 (Admission), Day 1 up to Days 47-48.
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of \[14C\]GRT6019
Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae)
时间窗: Day -1 (Admission), Day 1 up to Days 47-48.
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of \[14C\]GRT6019
Metabolite profling and structural identification
时间窗: Day -1 (Admission), Day 1 up to Days 47-48.
To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples
次要结局
未报告次要终点