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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. 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. The effect of food on PK/PD of FYU-981 is also investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FYU-981 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981, (Oral single dosing) | Drug | Subjects randomized to the FYU-981 arm receive active drug, FYU-981. |
|
| 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 (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 | |
| Pharmacokinetics (CLr: Renal clearance) | 48 hours |
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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 single dosing) | Drug | Subjects randomized to the placebo arm receive placebo. |
|