Renal PK Study of LC350189

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment

Conditions
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Gout, Hyperuricemia

Intervention / Treatment
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* Drug: LC350189 200 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The subject has a BMI of 18 to 40 kg/m2, inclusive, at screening. The subject is able to provide written informed consent. 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 The subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator. The subject has nephrotic syndrome, defined as serum albumin <3.0 g/dL and urine protein/creatinine ratio >350 mg/mmol (as an estimate of approximate proteinuria of >3.5 g/day) at screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Normal (control) renal function<br> | Drug: LC350189 200 mg<br>* Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7<br>|
| Experimental: B: Mild impairment renal function<br> | Drug: LC350189 200 mg<br>* Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7<br>|
| Experimental: C: Moderate impairment renal function<br> | Drug: LC350189 200 mg<br>* Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7<br>|
| Experimental: D: Severe impairment renal function<br> | Drug: LC350189 200 mg<br>* Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Before dosing on Days 1 through Day 8 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) |