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This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the PK, PD, safety, and tolerability of LC350189 and colchicine when administered alone and in combination in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental | Period 1: LC350189 200mg Day 1~ Day 4 qd, Period 2: Colchicine 0.6 mg Day 8 ~ Day 15 bid, Period 3 : LC350189 200mg (qd) + Colchicine 0.6 mg (bid) Day 16~ 19 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanthine Oxidase Inhibitor | Drug | LC350189 200mg qd |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma | Pharmacokinetic | from baseline up to Day 21 |
| Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma | Pharmacokinetic | from baseline up to Day 21 |
| 3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma | Pharmacokinetic | from baseline up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Safety | from baseline up to Day 21 |
| Changes in uric serum acid | Pharmacodynamic | from baseline up to Day 19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |