Renal PK Study of LC350189

Completed · Phase 1

Conditions studied: Gout, Hyperuricemia

In brief

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.

Key facts

Study ID

NCT04066712

Run by

LG Chem

People needed

37

Starts

2019-11-19

Expected to finish

2020-09-12

Last updated by the study team

2020-09-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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