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Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]JAB-21822
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]JAB-21822 | Experimental | Single oral dose of 800mg 14C]JAB-2182 suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]JAB-21822 | Drug | Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of total radioactivity in urine and fecal samples | Mass balance recovery of total radioactivity in urine and fecal samples | up to 504 hours post dose |
| Total radioactivity in plasma PK: Cmax | Highest radioactivity observed plasma concentration | up to 504 hours post dose |
| Total radioactivity in plasma PK: Area under the curve | Area under the plasma concentration time curve | up to 504 hours post dose |
| Total radioactivity in plasma PK: t1/2 | Elimination half-life | up to 504 hours post dose |
| Total radioactivity in plasma PK: MRT | Mean residence time | up to 504 hours post dose |
| Total radioactivity in plasma PK: Tmax | Time for Cmax | up to 504 hours post dose |
| Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples | Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites | up to 504 hours post dose |
| Whole blood to plasma total radioactivity ratio |
| Measure | Description | Time Frame |
|---|---|---|
| JAB-21822 PK: Cmax | Highest observed plasma concentration of JAB-21822 | up to 504 hours post dose |
| JAB-21822 PK: Area under the curve | Area under the plasma concentration time curve of JAB-21822 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miao Liyan doctor of pharmacy | 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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| up to 504 hours post dose |
| up to 504 hours post dose |
| JAB-21822 PK: t1/2 | Elimination half-life of JAB-21822 | up to 504 hours post dose |
| JAB-21822 PK: MRT | Mean residence time of JAB-21822 | up to 504 hours post dose |
| JAB-21822 PK: Tmax | Time for Cmax of JAB-21822 | up to 504 hours post dose |
| Number of participants with adverse events | All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments | up to 504 hours post dose |