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Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal liver function | Experimental | Patients will receive single dose of SHR4640 |
|
| Mild Hepatic Impairment | Experimental | Patients will receive single dose of SHR4640 |
|
| Moderate Hepatic Impairment | Experimental | Patients will receive single dose of SHR4640 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | orally SHR4640 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing |
| Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) | Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing |
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Inclusion Criteria:
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All subjects:
Normal liver function:
• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.
Hepatic impaired subjects:
Exclusion Criteria:
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All subjects:
• Subject known or suspected of being sensitive to the study drugs or its ingredient.
Normal liver function:
Hepatic impaired subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meixia Wang | Beijing | Beijing Municipality | 100069 | China |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
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