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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Fuji Yakuhin Co., Ltd.

Current Primary Outcome:

  • Pharmacodynamics (Amount of uric acid excreted in urine) [ Time Frame: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day ]
  • Pharmacodynamics (Renal clearance of uric acid) [ Time Frame: 1-, 4- and 7-day ]
  • Pharmacodynamics (Fractional uric acid excretion) [ Time Frame: 4- and 7-day ]
  • Pharmacodynamics (Maximum delta effective uric acid concentration) [ Time Frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day ]
  • Pharmacodynamics (Delta area under the serum uric acid concentration-time curve) [ Time Frame: 1-, 4- and 7-day ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics (Cmax: Maximum plasma concentration) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (Cmin: Minimum plasma concentration) [ Time Frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day ]
  • Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (AUC: Area under the plasma concentration-time curve) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (kel: Elimination rate constant) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) [ Time Frame: 1-, and 7-day ]
  • Pharmacokinetics (MRT: Mean residence time) [ Time Frame: 1-, and 7-day ]


Original Secondary Outcome: Same as current

Information By: Fuji Yakuhin Co., Ltd.

Dates:
Date Received: July 15, 2016
Date Started: July 2016
Date Completion: December 2017
Last Updated: April 30, 2017
Last Verified: July 2016