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This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]-Jaktinib orally in Chinese healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-Jaktinib | Experimental | Subjects will receive single dose of [14C]-Jaktinib (Suspension, 100mg/150μCi) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-Jaktinib | Drug | Subjects will receive single dose of orally [14C]-Jaktinib on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples) | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces. | From the start of administration to 240 hours after administration |
| Identification of the Proportion of different metabolites to determine biotransformation pathway of Jaktinib | Proportion of different metabolites(Jaktinib and main metabolites) | From the start of administration to 240 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitive analysis of the concentrations of Jaktinib and main metabolites in plasma to obtain pharmacokinetic data | The concentrations of Jaktinib and main metabolites in plasma | From the start of administration to 240 hours after administration |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| liyan Miao, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of soochow University | Suzhou | Jiangsu | China |
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Adverse events assessed by CTCAE v5.0. |
| From the start of administration to 17days after administration |