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The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]HRS-1780 following an oral single dose in healthy adult male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]HRS-1780 Group | Experimental | Oral, single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]HRS-1780 | Drug | [14C]HRS-1780, oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity ratio of whole blood/plasma. | 0 to anticipated 11 days. | |
| Tmax | Time to reach maximum concentration (Tmax). | 0 to anticipated 11 days. |
| Cmax | Maximum concentration (Cmax). | 0 to anticipated 11 days. |
| AUClast | Area under the concentration time curve from time point 0 to the last quantifiable time point (AUClast). | 0 to anticipated 11 days. |
| AUC0-inf | Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf). | 0 to anticipated 11 days. |
| t1/2 | Half-life (t1/2). | 0 to anticipated 11 days. |
| CL/F | Apparent clearance (CL/F). | 0 to anticipated 11 days. |
| Vz/F | Apparent volume of distribution (Vz/F). | 0 to anticipated 11 days. |
| %AUC | Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC). |
| 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 | |
|---|---|---|---|---|
| Jing He | Contact | +86-0518-82342973 | jing.he@hengrui.com | |
| Yue Fei | Contact | +86-0518-82342973 | yue.fei@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital, Affiliated to Shandong First Medical University | Jinan | Shandong | 250013 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Single-dose, non-randomized, open-label study.
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| 0 to anticipated 11 days. |
| %Dose | Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose). | 0 to anticipated 11 days. |
| 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |