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This experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard. On the first day of the experiment, each subject orally took a single dose of [14C] AL8326 oral formulation containing approximately 60mg (200 μ Ci). During the experiment, whole blood, plasma, urine, and fecal samples were collected at designated time points/time periods.
This experiment adopts a single center, open label, non randomized, single dose trial design. By measuring the total radioactivity, calculate the ratio of total radioactivity in whole blood to plasma of [14C] AL8326, pharmacokinetic parameters, recovery rate, and excretion pathway data of total radioactivity in plasma. At the same time, by identifying the spectra of radioactive metabolites and the structures of major metabolites in plasma, urine, and feces, the main metabolic elimination pathways and characteristics of AL8326 in the human body were obtained, as well as the circulating metabolites that are close to or higher than 10% of the total radioactive exposure in plasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-labeled AL8326 | Experimental | Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-labeled AL8326 | Drug | Oral, About 60mg (200μCi) of 14C-labeled AL8326 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Material balance | the cumulative excretion rate of total radioactive material in excreta (urine and feces); | All excreted urine and feces samples at specified time points during 0-480 hours after dosing will be collected. |
| Metabolites | The percentage of the original drug and each metabolite in urine and feces (% dose) | Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol |
| Metabolites | The AUC percentage of the original drug and circulating metabolites in plasma (%AUC) were calculated; | Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol |
| Pharmacokinetic | Pharmacokinetic parameters for total radioactivity in plasma, including peak concentration (Cmax), time to peak (Tmax), area under the drug-time curve (AUC0-t and AUC0-∞), elimination half-life (t1/2), apparent clearance (CL/F), apparent volume of distribution (Vd/F) and mean residence time (MRT). ) and mean residence time (MRT). | Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol |
| whole blood | whole blood to plasma total radioactivity partition ratio | Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics | PK parameters of AL8326 and its main metabolites in plasma, including peak concentration (Cmax), time to peak (Tmax), area under the drug-time curve (AUC0-t and AUC0-∞), elimination half-life (t1/2), apparent clearance (CL/F), apparent volume of distribution (Vd/F) and mean residence time (MRT). ) and mean residence time (MRT). | Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for this study:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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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 | 215006 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Safety | Number of participants with adverse events/drug-related adverse events, with abnormal physical examination findings, abnormal vital signs, abnormal 12-lead electrocardiogram, and abnormal laboratory tests results | From signing the ICF until 22 days after the first dosing |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |