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Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] D-1553 group | Other | Single arm study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] D-1553 | Drug | [14C] D-1553 (approximately 400 mg/80 μCi) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The radioactivity will be determined by a liquid scintillation counter. Analyze the total recovery (that is the ratio of the radioactivity in excrement samples to the radioactivity of the drug that administered ) in excrement | Recovery and cumulative recovery of total radioactive substance in excrement (urine and feces) | 2 weeks |
| Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose | Exposure in plasma; percentage of unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces | 2 weeks |
| whole blood/plasma ratio for TRA (total radioactivity) concentration at different time points | whole blood/plasma ratio for TRA concentration at different time points | 2 weeks |
| Tmax (time to maximum observed concentration) parameters of TRA; | Tmax parameters of TRA in plasma | baseline to 2 weeks |
| t1/2 (terminal elimination half-life) parameters of TRA; | t1/2 parameters of TRA in plasma | baseline to 2 weeks |
| Cmax (maximum concentration) parameters of TRA; | Cmax parameters of TRA in plasma | baseline to 2 weeks |
| MRT (mean residence time) parameters of TRA; | MRT parameters of TRA in plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs based on NCI CTCAE V5.0 | Incidence and severity of adverse events (AEs) graded based on NCI CTCAE V5.0 | baseline to 3 weeks |
| Incidence and severity of SAEs based on NCI CTCAE V5.0 |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Chinese adult male subjects aged 19-55 years (inclusive) at the time of signing the ICF.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| beijing Gobroad Boren Hospital | Beijing | China |
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| baseline to 2 weeks |
| AUC (area under curve) parameters of TRA; | AUC parameters of TRA in plasma | baseline to 2 weeks |
Incidence and severity of serious adverse events (SAEs) graded based on NCI CTCAE V5.0
| baseline to 3 weeks |
| Tmax parameters of D-1553 and its metabolites | Tmax parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |
| Cmax parameters of D-1553 and its metabolites | Cmax parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |
| AUC0-t parameters of D-1553 and its metabolites | AUC0-t parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |
| T1/2 parameters of D-1553 and its metabolites | T1/2 parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |
| MRT parameters of D-1553 and its metabolites | MRT parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |
| CL/F (apparent clearance) parameters of D-1553 and its metabolites | CL/F parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |
| Vz/F (apparent volume of distribution) parameters of D-1553 and its metabolites | Vz/F parameters of D-1553 and its metabolites (if applicable) in plasma | baseline to 2 weeks |