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CompletedNCT04139824Updated Jun 26, 2020

The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults

A Phase 1 interventional study of Xanthine Oxidase Inhibitor and nonsteroidal anti-inflammatory drug in Gout and Hyperuricemia, sponsored by LG Chem. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-26.

Sponsored by LG Chem · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2020, 6 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects.

02

Conditions studied

  • Gout
  • Hyperuricemia

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03

In context

Hyperuricemia

215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.

This study's enrollment of 24 is below the median of 64 across 172 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The subject is male or female 18 to 50 years of age, inclusive.
  • The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
  • The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening.
  • The subject agrees to comply with all protocol requirements.
  • The subject is able to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  • The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator.
  • The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
  • The subject has an estimated glomerular filtration rate (eGFR) of \<90 (mL/min)/1.73 m2.
  • The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study.
  • The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study.
  • The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
  • The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
  • The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Cohort

    Period 1: LC350189 200mg (QD) Day 1\~ Day 4, Period 2: Naproxen 500 mg (BID) Day 8 \~ Day 12 , Period 3 : LC350189 200mg (QD) + Naproxen 500 mg (BID) Day 13\~19

    Drug: Xanthine Oxidase Inhibitor · Drug: nonsteroidal anti-inflammatory drug

Interventions

  • DrugXanthine Oxidase Inhibitor

    LC350189 200mg qd

    Also known as: LC350189

  • Drugnonsteroidal anti-inflammatory drug

    Naproxen 500mg BID

    Also known as: Naproxen

06

What researchers measure

Primary outcomes

  1. Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma

    Pharmacokinetic

    Time frame: From baseline up to Day 18

  2. Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma

    Pharmacokinetic

    Time frame: From baseline up to Day 18

  3. Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma

    Pharmacokinetic

    Time frame: From baseline up to Day 18

Secondary outcomes

  1. Incidence of Adverse events

    Safety

    Time frame: From baseline up to Day 18

  2. Changes in concentration of uric acid in plasma by uricase method

    Pharmacodynamic

    Time frame: From baseline up to Day 17

07

Study locations

1 site
  • PPD
    Austin, Texas 78744, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04139824
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Oct 25, 2019
Start date
Jan 22, 2020
Primary completion
Feb 25, 2020
Completion
Feb 25, 2020
Last update
Jun 26, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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