Renal PK Study of LC350189

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066712
• Other study ID #: LG-GDCL003
• Status: Completed
• Phase: Phase 1
• Start date: November 19, 2019
• Est. completion date: September 12, 2020

Study information

• Verified date: November 2019
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 12, 2020
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• LC350189 200 mg
Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC from time 0 to the last quantifiable concentration	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	AUC from time 0 to 24 hours post dose	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	AUC from time 0 to the end of the dosing interval at steady state	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	Maximum observed plasma concentration	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	Maximum observed plasma concentration at steady state	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	Time to reach maximum observed plasma concentration	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	Time to reach maximum observed plasma concentration at steady state	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Primary	Amount of drug excreted in urine (Ae) over each collection interval	Pharmacokinetic Assessments	Before dosing on Days 1 through Day 8
Secondary	Serum mean concentration over 24 hours	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)	Before dosing on Days 1 through Day 8
Secondary	Maximum observed effect	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)	Before dosing on Days 1 through Day 8
Secondary	Time to reach maximum effect	Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)	Before dosing on Days 1 through Day 8
Secondary	Incidence of adverse events	Safety	Days 1 through Day 9 (end of study)