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This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]HRS-8080 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]HRS-8080 | Drug | Subjects will receive single dose of orally [14C]HRS-8080. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative amount of HRS-8080 excreted. | 0 hour to 360 hours. | |
| Percentage of parent drug and its metabolite(s) relative to total radioactive exposure in plasma. | 0 hour to 360 hours. | |
| Percentage of administered dose excreted as parent drug and its metabolite(s) in urine. | 0 hour to 360 hours. | |
| Percentage of administered dose excreted as parent drug and its metabolite(s) in feces. | 0 hour to 360 hours. | |
| Maximum concentration (Cmax). | Pharmacokinetic parameters for total radioactivity in plasma. | 0 hour to 336 hours. |
| Time of maximum concentration (Tmax). | Pharmacokinetic parameters for total radioactivity in plasma. | 0 hour to 336 hours. |
| Area under the concentration-time curve (AUC). | Pharmacokinetic parameters for total radioactivity in plasma. | 0 hour to 336 hours. |
| Elimination half-life (t1/2). | Pharmacokinetic parameters for total radioactivity in plasma. | 0 hour to 336 hours. |
| Apparent clearance (CL/F). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax). | Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma. | 0 hour to 336 hours. |
| Time of maximum concentration (Tmax). | Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Pharmacokinetic parameters for total radioactivity in plasma.
| 0 hour to 336 hours. |
| Apparent volume of distribution (Vz/F). | Pharmacokinetic parameters for total radioactivity in plasma. | 0 hour to 336 hours. |
| Ratio of total radioactivity in whole blood to plasma. | 0 hour to 360 hours. |
| 0 hour to 336 hours. |
| Area under the concentration-time curve (AUC). | Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma. | 0 hour to 336 hours. |
| Elimination half-life (t1/2). | Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma. | 0 hour to 336 hours. |
| Apparent clearance (CL/F). | Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma. | 0 hour to 336 hours. |
| Apparent volume of distribution (Vz/F). | Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma. | 0 hour to 336 hours. |
| Adverse events (AEs). | Day -7 to Day 23. |
| D017437 |
| Skin and Connective Tissue Diseases |