Hyperuricemia
Conditions
Keywords
Hyperuricemia
Brief summary
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.
Interventions
DRUGKUX-1151
Sponsors
Kissei Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Japanese HU patients (Outpatient) * Patients who meet the following criteria concerning serum uric acid levels at the screening \[1) Gout: \> 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL\]
Exclusion criteria
* Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL | 14 weeks |
| Percent change from baseline in serum uric acid level | 14 weeks |
| Change from baseline in serum uric acid level | 14 weeks |
Countries
Japan
Outcome results
None listed