- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361646
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
June 10, 2013 updated by: LG Life Sciences
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics.
Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
Study Overview
Study Type
Interventional
Enrollment (Actual)
129
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
-
-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
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
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects between the ages of 20 and 50 years at screening
- Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}2.
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
|
Active Comparator: Febuxostat
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Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
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Experimental: LC350189
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Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events of LC350189
Time Frame: 7 days(plus or minus 1 day)
|
7 days(plus or minus 1 day)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax
Time Frame: 3 days
|
3 days
|
AUC
Time Frame: 3days
|
3days
|
Tmax
Time Frame: 3days
|
3days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyung Sang Yu, MD, PhD, Seoul National University Hospital
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
June 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
May 19, 2011
First Submitted That Met QC Criteria
May 25, 2011
First Posted (Estimate)
May 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 11, 2013
Last Update Submitted That Met QC Criteria
June 10, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-GDCL001
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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