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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927677
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
LG Chem

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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: Xanthine Oxidase Inhibitor Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2019
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : November 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout

Arm Intervention/treatment
Experimental: 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
Drug: Xanthine Oxidase Inhibitor
LC350189 200mg qd
Other Name: LC350189




Primary Outcome Measures :
  1. Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma [ Time Frame: from baseline up to Day 21 ]
    Pharmacokinetic

  2. Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma [ Time Frame: from baseline up to Day 21 ]
    Pharmacokinetic

  3. 3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma [ Time Frame: from baseline up to Day 21 ]
    Pharmacokinetic


Secondary Outcome Measures :
  1. Incidence of Adverse events [ Time Frame: from baseline up to Day 21 ]
    Safety

  2. Changes in uric serum acid [ Time Frame: from baseline up to Day 19 ]
    Pharmacodynamic



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927677


Locations
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United States, Texas
PPD
Austin, Texas, United States, 78744
Sponsors and Collaborators
LG Chem
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03927677    
Other Study ID Numbers: LG-GDCL004
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes