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To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type.
In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uric acid-overproduction Type | Experimental | FYU-981 |
|
| Uric acid- underexcretion Type | Experimental | FYU-981 |
|
| Uric acid-overproduction Type (combination) | Experimental | FYU-981 , Topiroxostat |
|
| Uric acid- underexcretion Type2 | Experimental | FYU-981 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (Amount of uric acid excreted in urine) | 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day | |
| Pharmacodynamics (Renal clearance of uric acid) | 1-, 4- and 7-day | |
| Pharmacodynamics (Fractional uric acid excretion) | 4- and 7-day | |
| Pharmacodynamics (Maximum delta effective uric acid concentration) | 1-, 2-, 3-, 4-, 5-, 6- and 7-day | |
| Pharmacodynamics (Delta area under the serum uric acid concentration-time curve) | 1-, 4- and 7-day |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 1-, and 7-day | |
| Pharmacokinetics (Cmin: Minimum plasma concentration) | 1-, 2-, 3-, 4-, 5-, 6- and 7-day | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31734820 | Derived | Okui D, Sasaki T, Fushimi M, Ohashi T. The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):92-102. doi: 10.1007/s10157-019-01817-3. Epub 2019 Nov 16. |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
| C504882 | FYX-051 |
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| Topiroxostat | Drug |
|
|
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |
| 1-, and 7-day |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 1-, and 7-day |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 1-, and 7-day |
| Pharmacokinetics (kel: Elimination rate constant) | 1-, and 7-day |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) | 1-, and 7-day |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 1-, and 7-day |
| Pharmacokinetics (MRT: Mean residence time) | 1-, and 7-day |