A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total radioactivity in plasma PK
研究概览
简要总结
This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.
In addition, this study will also evaluate the safety of a single dose of [14C]GB491 when given to healthy subjects.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male volunteer between 18 and 50 years of age inclusive
- •A total body weight >=50kg, and a BMI of 19.0-26.0 kg/m2
- •A signed informed consent document
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Subjects with HBsAg-positive, or HCV-Ab-positive, or TPPA-positive, or HIV infection
- •Subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease
研究组 & 干预措施
[14C]GB491
干预措施: [14C]GB491 (Drug)
结局指标
主要结局
Total radioactivity in plasma PK
时间窗: Up to 168 hours post dose
To investigate the distribution ratio of total radioactivity in whole blood to plasma and pharmacokinetic characteristics of total radioactivity in plasma in healthy subjects after a single dose of \[14C\]GB491.
Total radioactivity in urine and fecal samples
时间窗: Up to 360 hours post dose
Quantitative analysis of total radioactivity in urine or feces in healthy subjects after a single dose of \[14C\]GB491.
Metabolite G1T30 and other major matabolites (if applicable)
时间窗: Up to 168 hours post dose
Identify the main metabolites in healthy subjects after oral administration of \[14C\]GB491 to determine the main biotransformation pathway
次要结局
- Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma(Up to 168 hours post dose)
- Adverse events(Up to 360 hours post dose)