Renal PK Study of LC350189

Phase 1

Completed

• Conditions: Hyperuricemia; Gout
• Interventions: Drug: LC350189 200 mg

• Registration Number: NCT04066712
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Status Verified: 2019-11
• Study Start: 2019-11-19
• Primary Completion: 2020-09-12
• Study Completion: 2020-09-12
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Normal (control) renal function	LC350189 200 mg	-
B: Mild impairment renal function	LC350189 200 mg	-
C: Moderate impairment renal function	LC350189 200 mg	-
D: Severe impairment renal function	LC350189 200 mg	-

Primary Outcome Measures

Name	Time	Method
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
Amount of drug excreted in urine (Ae) over each collection interval	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
Maximum observed plasma concentration	Before dosing on Days 1 through Day 8	Pharmacokinetic Assessments

Secondary Outcome Measures

Name	Time	Method
Serum mean concentration over 24 hours	Before dosing on Days 1 through Day 8	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
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

Trial Locations

Locations (1)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States