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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: Xanthine Oxidase Inhibitor; Drug: nonsteroidal anti-inflammatory drug

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: LC350189; Drug: nonsteroidal anti-inflammatory drug; Naproxen 500mg BID; Other Names: Naproxen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma	Pharmacokinetic	From baseline up to Day 18
Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma	Pharmacokinetic	From baseline up to Day 18
Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma	Pharmacokinetic	From baseline up to Day 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse events	Safety	From baseline up to Day 18
Changes in concentration of uric acid in plasma by uricase method	Pharmacodynamic	From baseline up to Day 17

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2020
• Primary Completion (ACTUAL): February 25, 2020
• Study Completion (ACTUAL): February 25, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Naproxen
• Other Study ID Numbers: LG-GDCL006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No