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

Phase 1

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: Xanthine Oxidase Inhibitor; Drug: nonsteroidal anti-inflammatory drug

• Registration Number: NCT04139824
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2020-01-22
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort	Xanthine Oxidase Inhibitor	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
Cohort	nonsteroidal anti-inflammatory drug	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse events	From baseline up to Day 18	Safety
Changes in concentration of uric acid in plasma by uricase method	From baseline up to Day 17	Pharmacodynamic

Trial Locations

Locations (1)

PPD; 🇺🇸 Austin, Texas, United States