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Phase II Exploratory Clinical Study of KUX-1151

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02190786
Enrollment
Unknown
Registered
2014-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia

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.
Lead SponsorINDUSTRY

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

MeasureTime frame
Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL14 weeks
Percent change from baseline in serum uric acid level14 weeks
Change from baseline in serum uric acid level14 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026