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A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]XZP-3287 | Experimental | Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]XZP-3287 | Drug | 360 mg suspension containing 50µCi of [14C] XZP-3287 |
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| Measure | Description | Time Frame |
|---|---|---|
| PK data for 14C-XZP-3287: Cmax | Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity | up to 15 days |
| PK data for 14C-XZP-3287: AUClast | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma and whole blood total radioactivity | up to 15 days |
| PK data for 14C-XZP-3287: AUCinf | Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity | up to 15 days |
| PK data for 14C-XZP-3287: Tmax | Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity | up to 15 days |
| Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces) | Quantitative analysis of total radioactivity in excreta after oral [14C]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways | up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of XZP-3287 in plasma | Maximum observed concentration for XZP-3287 in plasma | up to 15 days |
| AUClast of XZP-3287 in plasma | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuilan Xiao | Contact | +86-13699167610 | xiaocuilan@xuanzhubio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gaobo Boren Hospital | Beijing | Beijing Municipality | 100070 | China |
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| up to 15 days |
| AUCinf of XZP-3287 in plasma | Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma | up to 15 days |
| Tmax of XZP-3287 in plasma | Time of maximum observed concentration for XZP-3287 in plasma | up to 15 days |
| To evaluate the safety of [14C] XZP-3287 | Percentage of Participants with Adverse Events (AEs) | up to 29 days |