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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837198
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hyperuricemia Drug: FYU-981 Drug: Topiroxostat Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
Study Start Date : July 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: Uric acid-overproduction Type
FYU-981
Drug: FYU-981
Experimental: Uric acid- underexcretion Type
FYU-981
Drug: FYU-981
Experimental: Uric acid-overproduction Type (combination)
FYU-981 , Topiroxostat
Drug: FYU-981
Drug: Topiroxostat
Other Name: FYX-051

Experimental: Uric acid- underexcretion Type2
FYU-981
Drug: FYU-981



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837198


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Fuji Yakuhin Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fuji Yakuhin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02837198    
Other Study ID Numbers: FYU-981-008
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
FYX-051
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action