Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
- Registration Number
- NCT02837198
- Lead Sponsor
- Fuji Yakuhin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Uric acid-overproduction Type FYU-981 FYU-981 Uric acid- underexcretion Type FYU-981 FYU-981 Uric acid-overproduction Type (combination) FYU-981 FYU-981 , Topiroxostat Uric acid- underexcretion Type2 FYU-981 FYU-981 Uric acid-overproduction Type (combination) Topiroxostat FYU-981 , Topiroxostat
- Primary Outcome Measures
Name Time Method Pharmacodynamics (Renal clearance of uric acid) 1-, 4- and 7-day Pharmacodynamics (Fractional uric acid excretion) 4- and 7-day Pharmacodynamics (Amount of uric acid excreted in urine) 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day Pharmacodynamics (Delta area under the serum uric acid concentration-time curve) 1-, 4- and 7-day Pharmacodynamics (Maximum delta effective uric acid concentration) 1-, 2-, 3-, 4-, 5-, 6- and 7-day
- Secondary Outcome Measures
Name Time Method 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