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This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects group | Experimental |
| |
| Mild renal impairment group | Experimental |
| |
| Moderate renal impairment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1780 | Drug | Single dose in each arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-Cmax | Maximum observed concentration of HRS-1780 | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-AUC0-inf | Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration | Start of Treatment to end of study (approximately 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-Tmax | Time to Cmax of HRS-1780 | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of HRS-1780 |
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Inclusion Criteria:
- Healthy subjects:
Renal impairment subjects:
Exclusion Criteria:
- Healthy subjects:
Renal impairment subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Fei | Contact | 0518-82342973 | yue.fei@hengrui.com |
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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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| Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-CL/F | Apparent clearance of HRS-1780 | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of HRS-1780 | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Cumulative excretion (Ae) | Cumulative amount of HRS-1780 excreted in urine | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Cumulative excretion rate (Ae%) | Cumulative percentage of HRS-1780 recovered in urine | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Renal clearance (CLr) | Clearance of HRS-1780 by kidney | Start of Treatment to end of study (approximately 1 week) |
| Binding rates of plasma protein (BRPP) of HRS-1780 | Binding rates of plasma protein | Start of Treatment to end of study (approximately 1 week) |
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 1 week) |
| 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 |