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The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Without Hepatic Impairment | Experimental |
| |
| Subjects With Mild Hepatic Impairment | Experimental |
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| Subjects With Moderate Hepatic Impairment | Experimental |
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| Subjects With Severe Hepatic Impairment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of HDM1002 on Day 1 | Drug | Single dose of HDM1002 will be administered on Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Maximum observed plasma of HDM1002 concentration. | Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose. |
| Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) | Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to infinite time. | Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose. |
| Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) | Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration. | Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose. |
| Fraction of Unbound Drug in Plasma (fu) | fu = Cu/C (where Cu represents unbound concentration and C represents total concentration). | Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyan Miao | Contact | 0512-67972858 | miaolysuzhou@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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