Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Primary Purpose
Hyperuricemia With or Without Gout
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
FYU-981
Sponsored by
About this trial
This is an interventional basic science trial for Hyperuricemia With or Without Gout
Eligibility Criteria
Inclusion Criteria:
Serum urate level:
- >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
- Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
- Outpatients
Exclusion Criteria:
- Gouty arthritis within 14 days before randomized allocation
Sites / Locations
- Mochida Investigational sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Uric acid-overproduction Type
Uric acid-underexcretion Type
Arm Description
Outcomes
Primary Outcome Measures
Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Amount of uric acid excreted in urine)
Secondary Outcome Measures
Full Information
NCT ID
NCT03375632
First Posted
December 10, 2017
Last Updated
September 21, 2018
Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03375632
Brief Title
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Official Title
Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia With or Without Gout
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uric acid-overproduction Type
Arm Type
Experimental
Arm Title
Uric acid-underexcretion Type
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FYU-981
Intervention Description
Oral daily dosing for 14 weeks
Primary Outcome Measure Information:
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
2-week
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
6-week
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
10-week
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
14-week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Serum urate level:
>= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
Outpatients
Exclusion Criteria:
Gouty arthritis within 14 days before randomized allocation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuki Furuno
Organizational Affiliation
Clinical Research Department
Official's Role
Study Director
Facility Information:
Facility Name
Mochida Investigational sites
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
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