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The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of famitinib in healthy adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib | Drug | a single oral dose of [14C]famitinib (25 mg/150 uCi suspension) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of total radioactivity in all excreta urine: CumAe and Cum%Ae | Amount and cumulative amount excreted and expressed as the percentage of the administered dose into the urine from time t1 to time t2 | 0-336 hours |
| Mass balance recovery of total radioactivity in all excreta feces: CumAe and Cum%Ae | Amount and cumulative amount excreted and expressed as the percentage of the administered dose into the feces from time t1 to time t2 | 0-336 hours |
| Total recovery of radioactivity in urine and feces as percentage of total radioactive dose administered | To characterize the extent of excretion of total radioactivity in urine and feces following administration of famitinib | 0-336 hours |
| Metabolic Profiling in Blood | Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in plasma if possible. | 0 to 240 hours |
| Metabolic Profiling in Urine | Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in urine if possible. | 0-336 hours |
| Metabolic Profiling in Feces | Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in feces if possible. | 0-336 hours |
| Ratio of radioactivity of whole blood and plasma blood |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs | 0-14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| C584390 | famitinib |
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Single oral dose of [14c]-Famitinib
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| 0-72 hours |
| Radioactivity AUC | 0-240 hours |
| Plasma famitinib and SHR116637: AUC | 0-240 hours |
| Plasma famitinib and SHR116637: Cmax | 0-240 hours |
| Plasma famitinib and SHR116637: Tmax | 0-240 hours |
| Radioactivity Tmax | 0-240 hours |
| Radioactivity Cmax | 0-240 hours |
| Plasma famitinib and SHR116637: t1/2 | 0-240 hours |
| Radioactivity t1/2 | 0-240 hours |