Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacodynamics (Renal clearance of uric acid)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Japanese adult subjects
- •Serum urate level: >= 7.0mg/dL in patients
- •Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type
排除标准
- •Gouty arthritis within a year before start of study treatment
- •Mixed type in the classification of hyperuricemia
研究组 & 干预措施
Uric acid-overproduction Type
FYU-981
干预措施: FYU-981 (Drug)
Uric acid- underexcretion Type
FYU-981
干预措施: FYU-981 (Drug)
Uric acid-overproduction Type (combination)
FYU-981 , Topiroxostat
干预措施: FYU-981 (Drug)
Uric acid-overproduction Type (combination)
FYU-981 , Topiroxostat
干预措施: Topiroxostat (Drug)
Uric acid- underexcretion Type2
FYU-981
干预措施: FYU-981 (Drug)
结局指标
主要结局
Pharmacodynamics (Renal clearance of uric acid)
时间窗: 1-, 4- and 7-day
Pharmacodynamics (Fractional uric acid excretion)
时间窗: 4- and 7-day
Pharmacodynamics (Amount of uric acid excreted in urine)
时间窗: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
时间窗: 1-, 4- and 7-day
Pharmacodynamics (Maximum delta effective uric acid concentration)
时间窗: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
次要结局
- 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)