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

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ClinicalTrials.gov Identifier: NCT04139824
Recruitment Status : Not yet recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
LG Chem

Brief 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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: Xanthine Oxidase Inhibitor Drug: nonsteroidal anti-inflammatory drug Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Fixed-sequence, 2-way Drug Interaction Study to Evaluate the Effect of Naproxen on the Pharmacokinetics of LC350189 and the Effect of LC350189 on the Pharmacokinetics of Naproxen in Healthy Subjects
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
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
LC350189 200mg qd
Other Name: LC350189

Drug: nonsteroidal anti-inflammatory drug
Naproxen 500mg BID
Other Name: Naproxen




Primary Outcome Measures :
  1. Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma [ Time Frame: From baseline up to Day 18 ]
    Pharmacokinetic

  2. Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma [ Time Frame: From baseline up to Day 18 ]
    Pharmacokinetic

  3. Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma [ Time Frame: From baseline up to Day 18 ]
    Pharmacokinetic


Secondary Outcome Measures :
  1. Incidence of Adverse events [ Time Frame: From baseline up to Day 18 ]
    Safety

  2. Changes in concentration of uric acid in plasma by uricase method [ Time Frame: From baseline up to Day 17 ]
    Pharmacodynamic



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139824


Contacts
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Contact: Younghwan Jang +82-2-6924-4154 younghj@lgchem.com

Sponsors and Collaborators
LG Chem

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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04139824    
Other Study ID Numbers: LG-GDCL006
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action