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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927677
• Other study ID #: LG-GDCL004
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2019
• Est. completion date: November 26, 2019

Study information

• Verified date: June 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• Xanthine Oxidase Inhibitor
LC350189 200mg qd

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma	Pharmacokinetic	from baseline up to Day 21
Primary	Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma	Pharmacokinetic	from baseline up to Day 21
Primary	3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma	Pharmacokinetic	from baseline up to Day 21
Secondary	Incidence of Adverse events	Safety	from baseline up to Day 21
Secondary	Changes in uric serum acid	Pharmacodynamic	from baseline up to Day 19