Phase II Exploratory Clinical Study of KUX-1151

Kissei

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: KUX-1151

Study type: Interventional

Funder types: Industry

Identifiers

NCT02190786

KUX1201

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

KUX-1151, Low dose

Experimental group

Treatment:

Drug: KUX-1151

KUX-1151, Middle dose

Experimental group

Treatment:

Drug: KUX-1151

KUX-1151, High dose

Experimental group

Treatment:

Drug: KUX-1151