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| Name | Class |
|---|---|
| Fuji Yakuhin Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal group | Experimental | Healthy control subjects |
|
| Mild hepatic-insufficient group | Experimental | Patients with mild hepatic impaired function (Child-Pugh A) |
|
| Moderate hepatic-insufficient group | Experimental | Patients with moderate hepatic impaired function (Child-Pugh B) |
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| Severe hepatic-insufficient group | Experimental | Patients with severe hepatic impaired function (Child-Pugh C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981 | Drug | Oral single dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours | |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours | |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 48 hours | |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 48 hours | |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 48 hours | |
| Pharmacokinetics (kel: Elimination rate constant) | 48 hours | |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) | 48 hours | |
| Pharmacokinetics (MRT: Mean residence time) | 48 hours | |
| Pharmacodynamics (Serum concentration of uric acid) | 48 hours | |
| Pharmacodynamics (Amount of uric acid excreted in urine) | 48 hours | |
| Safety (Incidence of treatment-emergent adverse events) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeki Matsumoto | Clinical Research Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mochida Investigational sites | Tokyo | Japan |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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| 192 hours |