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Study to Evaluate Pharmacokinetics and Safety of SHR0302 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 SHR0302 |
|
| Mild Hepatic Impairment | Experimental | Patients will receive single dose of SHR0302 |
|
| Moderate Hepatic Impairment | Experimental | Patients will receive single dose of SHR0302 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | SHR0302 |
|
| 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 |
| Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration (AUC0-t) | Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration (AUC0-t) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of Participants With Adverse Events and Serious Adverse Events | 72 hours after dosing |
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Inclusion Criteria:
All subjects::
Normal liver function:
Hepatic impaired subjects:
Exclusion Criteria:
All subjects:
Normal liver function:
Hepatic impaired subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jilin University | Changchun | Jilin | China |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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