Status:
COMPLETED
Renal PK Study of LC350189
Lead Sponsor:
LG Chem
Conditions:
Gout
Hyperuricemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04066712
Start Date
November 19 2019
End Date
September 12 2020
Last Update
September 21 2020
Active Locations (1)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809