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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]ICP-022 | Experimental | Subjects will take a single of 150mg 100μCi of [14C]ICP-022. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]ICP-022 | Drug | 150mg suspension containing 100μCi of [14C]ICP-022 |
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| Measure | Description | Time Frame |
|---|---|---|
| Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022 | 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. | Up to14 days |
| Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers | Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways | Up to14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative analysis of the concentration of ICP-022 in plasma | Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022 | Up to14 days |
| The biotransformation pathways of [14C]ICP-022 |
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key Inclusion criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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Urine and fecal collection for metabolite profiling. Identify the main metabolites in humans after oral [14]ICP-022 in healthy volunteers to determine the main biotransformation pathways.
| Up to14 days |