NCT02190786

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

First QC Date

July 11, 2014

Last Update Submit

October 16, 2015

Conditions

Hyperuricemia

Keywords

Hyperuricemia

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

KUX-1151, Low dose

EXPERIMENTAL
Drug: KUX-1151

KUX-1151, Middle dose

EXPERIMENTAL
Drug: KUX-1151

KUX-1151, High dose

EXPERIMENTAL
Drug: KUX-1151

Interventions

KUX-1151DRUG
KUX-1151, High doseKUX-1151, Low doseKUX-1151, Middle dose

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese HU patients (Outpatient)
  • Patients who meet the following criteria concerning serum uric acid levels at the screening \[1) Gout: \> 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL\]

You may not qualify if:

  • Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Primary Completion

March 1, 2015

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

JP(1)