Gout, Hyperuricemia
Conditions
Brief summary
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.
Interventions
DRUGLC350189 200 mg
Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Sponsors
LG Chem
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of drug excreted in urine (Ae) over each collection interval | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| Maximum observed plasma concentration | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| Maximum observed plasma concentration at steady state | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| Time to reach maximum observed plasma concentration | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| Time to reach maximum observed plasma concentration at steady state | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| AUC from time 0 to the last quantifiable concentration | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| AUC from time 0 to 24 hours post dose | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
| AUC from time 0 to the end of the dosing interval at steady state | Before dosing on Days 1 through Day 8 | Pharmacokinetic Assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed effect | Before dosing on Days 1 through Day 8 | Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine) |
| Time to reach maximum effect | Before dosing on Days 1 through Day 8 | Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine) |
| Incidence of adverse events | Days 1 through Day 9 (end of study) | Safety |
| Serum mean concentration over 24 hours | Before dosing on Days 1 through Day 8 | Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine) |
Countries
United States
Outcome results
None listed