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Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-Larotinib(Z650)in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-Larotinib | Experimental | Patients will receive single dose of [14C]-Larotinib (Suspension, 350mg/100μCi). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-Larotinib | Drug | Patients will receive single dose of orally [14C]-Larotinib on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion of 14C-labeled drug-related material (radioactivity in plasma, urine and fecal samples) | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces. | up to 15 days |
| Identification of the Proportion of different metabolites to determine biotransformation pathway of Larotinib | Proportion of different metabolites(Larotinib and main metabolites) . | up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitive analysis of the concentrations of Larotinib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data | The concentrations of Larotinib in plasma | up to 15 days |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| liyan Miao, MD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
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Adverse events assessed by CTCAE v5.0.
| up to 22 days |