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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FYU-981 | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981, (Oral daily dosing for 7 days) | Drug | Subjects randomized to the FYU-981 arm receive active drug, FYU-981. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 1-, 4-, and 7-day | |
| Pharmacokinetics (Cmin: Minimum plasma concentration) | 1-, 2-, 3-, 4-, 5-, 6- and 7-day | |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 1-, 4-, and 7-day | |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 1-, 4-, and 7-day | |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 1-, 4-, and 7-day | |
| Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24) | 4-, and 7-day | |
| Pharmacokinetics (kel: Elimination rate constant) | 1-, 4-, and 7-day | |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 1-, 4-, and 7-day | |
| Pharmacokinetics (Ae: Amount of drug excreted in urine) | 9 days | |
| Pharmacokinetics (fe: Fraction of dose excreted in urine) | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Tokyo | Japan |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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| Placebo, (Oral daily dosing for 7 days) | Drug | Subjects randomized to the placebo arm receive placebo. |
|