Renal PK Study of LC350189

A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment

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 Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: LC350189 200 mg

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: Normal (control) renal function	Drug: LC350189 200 mg; Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Experimental: B: Mild impairment renal function	Drug: LC350189 200 mg; Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Experimental: C: Moderate impairment renal function	Drug: LC350189 200 mg; Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Experimental: D: Severe impairment renal function	Drug: LC350189 200 mg; Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC from time 0 to the last quantifiable concentration	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
AUC from time 0 to 24 hours post dose	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
AUC from time 0 to the end of the dosing interval at steady state	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Maximum observed plasma concentration	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Maximum observed plasma concentration at steady state	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Time to reach maximum observed plasma concentration	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Time to reach maximum observed plasma concentration at steady state	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Amount of drug excreted in urine (Ae) over each collection interval	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum mean concentration over 24 hours	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)	Before dosing on Days 1 through Day 8
Maximum observed effect	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)	Before dosing on Days 1 through Day 8
Time to reach maximum effect	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)	Before dosing on Days 1 through Day 8
Incidence of adverse events	Safety	Days 1 through Day 9 (end of study)

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): September 12, 2020
• Study Completion (Actual): September 12, 2020

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: LG-GDCL003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No