Renal PK Study of LC350189

NCT04066712 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-GDCL003
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Serum mean concentration over 24 hours

  Before dosing on Days 1 through Day 8

• Maximum observed effect

  Before dosing on Days 1 through Day 8

• Time to reach maximum effect

  Before dosing on Days 1 through Day 8

• Incidence of adverse events

  Days 1 through Day 9 (end of study)

Study Arms (4)

A: Normal (control) renal function

EXPERIMENTAL

Drug: LC350189 200 mg

B: Mild impairment renal function

EXPERIMENTAL

Drug: LC350189 200 mg

C: Moderate impairment renal function

EXPERIMENTAL

Drug: LC350189 200 mg

D: Severe impairment renal function

EXPERIMENTAL

Drug: LC350189 200 mg

Interventions

LC350189 200 mg DRUG

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

A: Normal (control) renal function; B: Mild impairment renal function; C: Moderate impairment renal function; D: Severe impairment renal function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: November 19, 2019
• Primary Completion: September 12, 2020
• Study Completion: September 12, 2020
• Last Updated: September 21, 2020

Record last verified: 2019-11

Locations

US (1)