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HRS-1893-107 is a Phase 1, single-center, non-randomized, open-label, single-dose study designed to investigate the mass balance, metabolism, and pharmacokinetics of [14C]HRS-1893. The study aims to quantify the radioactive recovery rate, determine the primary excretion pathways, evaluate the whole blood-to-plasma radioactivity ratio, identify major metabolites, and characterize the pharmacokinetic (PK) profile of HRS-1893 and its metabolites. Safety and tolerability will be monitored throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]HRS-1893 Group | Experimental | [14C]HRS-1893. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]HRS-1893 | Drug | [14C]HRS-1893 suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity ratio of whole blood/plasma | 0 to anticipated 11 days. | |
| Time to reach maximum concentration (Tmax) | 0 to anticipated 11 days. | |
| Maximum concentration (Cmax) | 0 to anticipated 11 days. | |
| Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t) | 0 to anticipated 11 days. | |
| Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞) | 0 to anticipated 11 days. | |
| Half-life (t1/2) | 0 to anticipated 11 days. | |
| Apparent clearance (CL/F) | 0 to anticipated 11 days. | |
| Apparent volume of distribution (V/F) | 0 to anticipated 11 days. | |
| Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC) | 0 to anticipated 11 days. | |
| Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose) | 0 to anticipated 11 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs | 0 to anticipated 11 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzheng Xiong | Contact | +86-0518-82342973 | wenzheng.xiong.wx10@hengrui.com | |
| Jing He | Contact | +86-0518-82342973 | jing.he@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangnan University Affiliated Hospital | Wuxi | Jiangsu | 214100 | China |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single-dose, non-randomized, open-label study.
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| Total radioactivity ratio for blood/plasma | 0 to anticipated 11 days. |
| The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces | 0 to anticipated 11 days. |