The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.

NCT ID: NCT03927677

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2019-11-26

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.

Conditions

Gout; Hyperuricemia

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Xanthine Oxidase Inhibitor

Intervention Type: DRUG

LC350189 200mg qd

Interventions

Xanthine Oxidase Inhibitor

LC350189 200mg qd

Intervention Type: DRUG

Other Intervention Names

LC350189

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD

Austin, Texas, United States

Countries

United States

Other Identifiers

LG-GDCL004

Identifier Type: -

Identifier Source: org_study_id