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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 renal insufficiency and with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderately-decreased group | Experimental | (eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2) |
|
| Slightly-decreased group | Experimental | (eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2) |
|
| Normal group | Experimental | (eGFR: >=90mL/min/1.73m^2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981, (Oral single dosing) | Drug | FYU-981, (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 | |
| Pharmacokinetics (Ae: Amount of drug excreted in urine) | 48 hours | |
| Pharmacokinetics (fe: Fraction of dose excreted in urine) | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Kagoshima | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31823130 | Derived | Fukase H, Okui D, Sasaki T, Fushimi M, Ohashi T, Hosoya T. Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):17-24. doi: 10.1007/s10157-019-01825-3. Epub 2019 Dec 10. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |