Back to resultsRenal PK Study of LC350189
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LC350189 200 mg
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
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.
Sites / Locations
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
A: Normal (control) renal function
B: Mild impairment renal function
C: Moderate impairment renal function
D: Severe impairment renal function
Arm Description
Outcomes
Primary Outcome Measures
AUC from time 0 to the last quantifiable concentration
Pharmacokinetic Assessments
AUC from time 0 to 24 hours post dose
Pharmacokinetic Assessments
AUC from time 0 to the end of the dosing interval at steady state
Pharmacokinetic Assessments
Maximum observed plasma concentration
Pharmacokinetic Assessments
Maximum observed plasma concentration at steady state
Pharmacokinetic Assessments
Time to reach maximum observed plasma concentration
Pharmacokinetic Assessments
Time to reach maximum observed plasma concentration at steady state
Pharmacokinetic Assessments
Amount of drug excreted in urine (Ae) over each collection interval
Pharmacokinetic Assessments
Secondary Outcome Measures
Serum mean concentration over 24 hours
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Maximum observed effect
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Time to reach maximum effect
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Incidence of adverse events
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04066712
Brief Title
Renal PK Study of LC350189
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
September 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: Normal (control) renal function
Arm Type
Experimental
Arm Title
B: Mild impairment renal function
Arm Type
Experimental
Arm Title
C: Moderate impairment renal function
Arm Type
Experimental
Arm Title
D: Severe impairment renal function
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LC350189 200 mg
Intervention Description
Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Primary Outcome Measure Information:
Title
AUC from time 0 to the last quantifiable concentration
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
AUC from time 0 to 24 hours post dose
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
AUC from time 0 to the end of the dosing interval at steady state
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
Maximum observed plasma concentration
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
Maximum observed plasma concentration at steady state
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
Time to reach maximum observed plasma concentration
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
Time to reach maximum observed plasma concentration at steady state
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Title
Amount of drug excreted in urine (Ae) over each collection interval
Description
Pharmacokinetic Assessments
Time Frame
Before dosing on Days 1 through Day 8
Secondary Outcome Measure Information:
Title
Serum mean concentration over 24 hours
Description
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Time Frame
Before dosing on Days 1 through Day 8
Title
Maximum observed effect
Description
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Time Frame
Before dosing on Days 1 through Day 8
Title
Time to reach maximum effect
Description
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Time Frame
Before dosing on Days 1 through Day 8
Title
Incidence of adverse events
Description
Safety
Time Frame
Days 1 through Day 9 (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Renal PK Study of LC350189
We'll reach out to this number within 24 hrs