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Completed

NCT Number: NCT04066712

Renal PK Study of LC350189

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LC350189 200 mg

Drug

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

Primary outcomes

  1. AUC from time 0 to the last quantifiable concentration

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  2. AUC from time 0 to 24 hours post dose

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  3. AUC from time 0 to the end of the dosing interval at steady state

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  4. Maximum observed plasma concentration

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  5. Maximum observed plasma concentration at steady state

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  6. Time to reach maximum observed plasma concentration

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  7. Time to reach maximum observed plasma concentration at steady state

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

  8. Amount of drug excreted in urine (Ae) over each collection interval

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacokinetic Assessments

Secondary outcomes

  1. Serum mean concentration over 24 hours

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)

  2. Maximum observed effect

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)

  3. Time to reach maximum effect

    Time frame: Before dosing on Days 1 through Day 8

    Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)

  4. Incidence of adverse events

    Time frame: Days 1 through Day 9 (end of study)

    Safety

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2019
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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