Renal PK Study of LC350189

LG Chem

Status and phase: Completed; Phase 1

Conditions: Hyperuricemia; Gout

Treatments: Drug: LC350189 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04066712

LG-GDCL003

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 4 patient groups

A: Normal (control) renal function

Experimental group

Treatment:

Drug: LC350189 200 mg

B: Mild impairment renal function

Experimental group

Treatment:

Drug: LC350189 200 mg

C: Moderate impairment renal function

Experimental group

Treatment:

Drug: LC350189 200 mg

D: Severe impairment renal function

Experimental group

Treatment:

Drug: LC350189 200 mg