A Phase 1, Open-label, Fixed-sequence, 2-way Drug Interaction Study to Evaluate the Effect of Colchicine on the Pharmacokinetics of LC350189 and the Effect of LC350189 on the Pharmacokinetics of Colchicine in Healthy Subjects

LG Chem1 site in 1 country24 target enrollmentNovember 5, 2019

ConditionsGout Hyperuricemia

InterventionsXanthine Oxidase Inhibitor

DrugsXanthine Oxidase Inhibitor

Overview

Phase: Phase 1
Intervention: Xanthine Oxidase Inhibitor
Conditions: Gout
Sponsor: LG Chem
Enrollment: 24
Locations: 1
Primary Endpoint: Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 5, 2019

End Date

November 26, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

LG Chem

Responsible Party

Sponsor

Eligibility 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 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.
•The subject is a female who is pregnant, planning to become pregnant within the next 6 months, or currently breastfeeding.
•In the opinion of the investigator, the subject is not suitable for entry into the study.

Arms & Interventions

Cohort

Period 1: LC350189 200mg Day 1\~ Day 4 qd, Period 2: Colchicine 0.6 mg Day 8 \~ Day 15 bid, Period 3 : LC350189 200mg (qd) + Colchicine 0.6 mg (bid) Day 16\~ 19

Intervention: Xanthine Oxidase Inhibitor