Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: FYU-981
* Drug: Topiroxostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese adult subjects Serum urate level: >= 7.0mg/dL in patients Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type Exclusion Criteria: Gouty arthritis within a year before start of study treatment Mixed type in the classification of hyperuricemia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uric acid-overproduction Type<br>FYU-981 | Drug: FYU-981<br> <br> |
| Experimental: Uric acid- underexcretion Type<br>FYU-981 | Drug: FYU-981<br> <br> |
| Experimental: Uric acid-overproduction Type (combination)<br>FYU-981 , Topiroxostat | Drug: FYU-981<br> <br> Drug: Topiroxostat<br> <br> * Other names: FYX-051;|
| Experimental: Uric acid- underexcretion Type2<br>FYU-981 | Drug: FYU-981<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |