Back to resultsStudy of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
Primary Purpose
Hyperuricemia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
FYU-981
Topiroxostat
Sponsored by
About this trial
This is an interventional basic science trial for Hyperuricemia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Uric acid-overproduction Type
Uric acid- underexcretion Type
Uric acid-overproduction Type (combination)
Uric acid- underexcretion Type2
Arm Description
FYU-981
FYU-981
FYU-981 , Topiroxostat
FYU-981
Outcomes
Primary Outcome Measures
Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Renal clearance of uric acid)
Pharmacodynamics (Fractional uric acid excretion)
Pharmacodynamics (Maximum delta effective uric acid concentration)
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
Secondary Outcome Measures
Pharmacokinetics (Cmax: Maximum plasma concentration)
Pharmacokinetics (Cmin: Minimum plasma concentration)
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Pharmacokinetics (kel: Elimination rate constant)
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Pharmacokinetics (MRT: Mean residence time)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02837198
Brief Title
Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
Official Title
Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuji Yakuhin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uric acid-overproduction Type
Arm Type
Experimental
Arm Description
FYU-981
Arm Title
Uric acid- underexcretion Type
Arm Type
Experimental
Arm Description
FYU-981
Arm Title
Uric acid-overproduction Type (combination)
Arm Type
Experimental
Arm Description
FYU-981 , Topiroxostat
Arm Title
Uric acid- underexcretion Type2
Arm Type
Experimental
Arm Description
FYU-981
Intervention Type
Drug
Intervention Name(s)
FYU-981
Intervention Type
Drug
Intervention Name(s)
Topiroxostat
Other Intervention Name(s)
FYX-051
Primary Outcome Measure Information:
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
Title
Pharmacodynamics (Renal clearance of uric acid)
Time Frame
1-, 4- and 7-day
Title
Pharmacodynamics (Fractional uric acid excretion)
Time Frame
4- and 7-day
Title
Pharmacodynamics (Maximum delta effective uric acid concentration)
Time Frame
1-, 2-, 3-, 4-, 5-, 6- and 7-day
Title
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
Time Frame
1-, 4- and 7-day
Secondary Outcome Measure Information:
Title
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (Cmin: Minimum plasma concentration)
Time Frame
1-, 2-, 3-, 4-, 5-, 6- and 7-day
Title
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (kel: Elimination rate constant)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame
1-, and 7-day
Title
Pharmacokinetics (MRT: Mean residence time)
Time Frame
1-, and 7-day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31734820
Citation
Okui D, Sasaki T, Fushimi M, Ohashi T. The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):92-102. doi: 10.1007/s10157-019-01817-3. Epub 2019 Nov 16.
Results Reference
derived
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Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
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