Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Sponsor
Mochida Pharmaceutical Company, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03375632
Collaborator
Fuji Yakuhin Co., Ltd. (Industry)
26
1
2
5
5.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
Actual Study Start Date
:
Jan 4, 2018
Actual Primary Completion Date
:
May 29, 2018
Actual Study Completion Date
:
Jun 5, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Uric acid-overproduction Type
|
Drug: FYU-981
Oral daily dosing for 14 weeks
|
| Experimental: Uric acid-underexcretion Type
|
Drug: FYU-981
Oral daily dosing for 14 weeks
|
Outcome Measures
Primary Outcome Measures
- Pharmacodynamics (Amount of uric acid excreted in urine) [2-week]
- Pharmacodynamics (Amount of uric acid excreted in urine) [6-week]
- Pharmacodynamics (Amount of uric acid excreted in urine) [10-week]
- Pharmacodynamics (Amount of uric acid excreted in urine) [14-week]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mochida Investigational sites | Tokyo | Japan |
Sponsors and Collaborators
- Mochida Pharmaceutical Company, Ltd.
- Fuji Yakuhin Co., Ltd.
Investigators
- Study Director: Kazuki Furuno, Clinical Research Department
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier:
NCT03375632
Other Study ID Numbers:
- FYU-981-013
First Posted:
Dec 18, 2017
Last Update Posted:
Sep 24, 2018
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: