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This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Normal (control) renal function | Experimental |
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| B: Mild impairment renal function | Experimental |
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| C: Moderate impairment renal function | Experimental |
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| D: Severe impairment renal function | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC350189 200 mg | Drug | Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7 |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC from time 0 to the last quantifiable concentration | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| AUC from time 0 to 24 hours post dose | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| AUC from time 0 to the end of the dosing interval at steady state | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| Maximum observed plasma concentration | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| Maximum observed plasma concentration at steady state | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| Time to reach maximum observed plasma concentration | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| Time to reach maximum observed plasma concentration at steady state | Pharmacokinetic Assessments | Before dosing on Days 1 through Day 8 |
| Amount of drug excreted in urine (Ae) over each collection interval | Pharmacokinetic Assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Serum mean concentration over 24 hours | Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine) | Before dosing on Days 1 through Day 8 |
| Maximum observed effect | Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine) |
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Inclusion Criteria
For healthy subjects only : The subject has normal renal function as determined by eGFR and calculated using the MDRD formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.
For subjects with renal impairment only
: The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | 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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| Before dosing on Days 1 through Day 8 |
| Before dosing on Days 1 through Day 8 |
| Time to reach maximum effect | Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine) | Before dosing on Days 1 through Day 8 |
| Incidence of adverse events | Safety | Days 1 through Day 9 (end of study) |
| 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 |