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

NCT03927677 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-GDCL004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma

  Pharmacokinetic

  from baseline up to Day 21

• Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma

  Pharmacokinetic

  from baseline up to Day 21

• 3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma

  Pharmacokinetic

  from baseline up to Day 21

Secondary Outcomes (2)

• Incidence of Adverse events

  from baseline up to Day 21

• Changes in uric serum acid

  from baseline up to Day 19

Study Arms (1)

Cohort

EXPERIMENTAL

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

Drug: Xanthine Oxidase Inhibitor

Interventions

Xanthine Oxidase Inhibitor DRUG

LC350189 200mg qd

Also known as: LC350189

Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: November 5, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (1)