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This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi [14C] APG-2575 to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]APG-2575 | Experimental | To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi [14C] APG-2575 to healthy subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C ]APG-2575 | Drug | orally, single dose of 400 mg / 200 μCi [14C] APG-2575 |
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| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity concentration of each blood and plasma sample | Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample. | Day 1- Day 8 |
| Radioactivity concentration in each urine and feces sample. | Use liquid scintillation counter to evaluate Radioactivity concentration of each sample. | Day 1- Day 15 |
| Number of metabolites and its proportion in plasma, urine and feces. | To elucidate the pathways of biotransformation. | Day 1- Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug concentrations | To determine the plasma concentrations of APG-2575 with LC-MS/MS. | Day 1- Day 8 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao | 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 | 215000 | China |
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According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.
| Day 1- Day 15 |