- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927677
The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
June 24, 2020 updated by: LG Chem
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78744
- PPD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
LC350189 200mg qd
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma
Time Frame: from baseline up to Day 21
|
Pharmacokinetic
|
from baseline up to Day 21
|
Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma
Time Frame: from baseline up to Day 21
|
Pharmacokinetic
|
from baseline up to Day 21
|
3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma
Time Frame: from baseline up to Day 21
|
Pharmacokinetic
|
from baseline up to Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse events
Time Frame: from baseline up to Day 21
|
Safety
|
from baseline up to Day 21
|
Changes in uric serum acid
Time Frame: from baseline up to Day 19
|
Pharmacodynamic
|
from baseline up to Day 19
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2019
Primary Completion (Actual)
November 26, 2019
Study Completion (Actual)
November 26, 2019
Study Registration Dates
First Submitted
April 23, 2019
First Submitted That Met QC Criteria
April 23, 2019
First Posted (Actual)
April 25, 2019
Study Record Updates
Last Update Posted (Actual)
June 26, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-GDCL004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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