Back to resultsThe Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Xanthine Oxidase Inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Gout
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.
Sites / Locations
- PPD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohort
Arm Description
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
Outcomes
Primary Outcome Measures
Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma
Pharmacokinetic
Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma
Pharmacokinetic
3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma
Pharmacokinetic
Secondary Outcome Measures
Incidence of Adverse events
Safety
Changes in uric serum acid
Pharmacodynamic
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03927677
Brief Title
The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Xanthine Oxidase Inhibitor
Other Intervention Name(s)
LC350189
Intervention Description
LC350189 200mg qd
Primary Outcome Measure Information:
Title
Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma
Description
Pharmacokinetic
Time Frame
from baseline up to Day 21
Title
Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma
Description
Pharmacokinetic
Time Frame
from baseline up to Day 21
Title
3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma
Description
Pharmacokinetic
Time Frame
from baseline up to Day 21
Secondary Outcome Measure Information:
Title
Incidence of Adverse events
Description
Safety
Time Frame
from baseline up to Day 21
Title
Changes in uric serum acid
Description
Pharmacodynamic
Time Frame
from baseline up to Day 19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
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