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To investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of [14C]Clifutinib, the distribution of total radioactivity in whole blood and plasma, and to determine the main excretion and metabolic pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Clifutinib | Experimental | On Day 1, subjects will receive a single oral dose of 40 mg/100 µCi [14C]Clifutinib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Clifutinib | Drug | The subjects are required to take the test drug on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ | Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of [14C] Clifutinib | From Day 1 of dosing to the Day 85 after dosing |
| Tmax | Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of [14C] Clifutinib | From Day 1 of dosing to the Day 85 after dosing |
| Cmax | Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of [14C] Clifutinib | From Day 1 of dosing to the Day 85 after dosing |
| Percentage of metabolites in plasma relative to total exposure AUC (% AUC) | Investigate the distribution of total radioactivity in plasma of male healthy subjects after a single oral administration of [14C] Clifutinib. | From Day 1 of dosing to the Day 85 after dosing |
| The total radioactivity | Quantitative analysis was conducted on the total radioactivity in the feces and urine of male health subjects after oral administration of [14C] Clifutinib, to obtain the data on human recovery rate and determine the main excretion pathway. | From Day 1 of dosing to the Day 85 after dosing |
| Identification of major metabolites in plasma, urine, and fecal samples | Obtain the radioactive metabolite profiles in plasma, urine and feces of male healthy subjects after oral administration of [14C]Clifutinib, identify the main metabolites, and determine the metabolic and elimination pathways. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ | The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters. | From Day 1 of dosing to the Day 85 after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Jiangnan University | Wuxi | Jiangsu | 214000 | China |
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| From Day 1 of dosing to the Day 85 after dosing |
| Tmax |
The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters. |
| From Day 1 of dosing to the Day 85 after dosing |
| Cmax | The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters. | From Day 1 of dosing to the Day 85 after dosing |
| Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc. | Observation of the safety profile in male healthy subjects after a single administration of [14C] Clifutinib | From Day 1 of dosing to the Day 85 after dosing |