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This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC350189 | Experimental |
| |
| Febuxostat | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC350189 | Drug | Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of LC350189 | 7 days(plus or minus 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 3 days | |
| AUC | 3days | |
| Tmax | 3days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Sang Yu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |