Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022
研究概览
简要总结
The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, blood coagulation routine, urine routine, stool routine + occult blood, serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior), abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other abnormalities and clinical significance.
- •ophthalmologic examination shows abnormality and clinical significance
- •Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody.
- •Within 1 month before the screening, having not limited to known as hepatic enzyme inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals) ;
- •Within 1 month before the screening, receiving the anticoagulant therapy such as warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
[14C]ICP-022
Subjects will take a single of 150mg 100μCi of [14C]ICP-022.
干预措施: [14C]ICP-022 (Drug)
结局指标
主要结局
Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022
时间窗: Up to14 days
To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma.
Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers
时间窗: Up to14 days
Quantitative analysis of total radioactivity in excreta after oral \[14C\] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways
次要结局
- Quantitative analysis of the concentration of ICP-022 in plasma(Up to14 days)
- The biotransformation pathways of [14C]ICP-022(Up to14 days)