Renal PK Study of LC350189

LG Chem37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gout Hyperuricemia

Interventions

LC350189 200 mgDRUG

Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Orlando Clinical Research Center

Orlando, Florida, United States