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Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361646
First Posted: May 27, 2011
Last Update Posted: June 11, 2013
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.
Information provided by (Responsible Party):
LG Life Sciences
May 19, 2011
May 27, 2011
June 11, 2013
June 2011
January 2013   (Final data collection date for primary outcome measure)
Adverse events of LC350189 [ Time Frame: 7 days(plus or minus 1 day) ]
Same as current
Complete list of historical versions of study NCT01361646 on ClinicalTrials.gov Archive Site
  • Cmax [ Time Frame: 3 days ]
  • AUC [ Time Frame: 3days ]
  • Tmax [ Time Frame: 3days ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
Not Provided
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hyperuricemia
  • Gout
Drug: LC350189
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
  • Experimental: LC350189
    Intervention: Drug: LC350189
  • Active Comparator: Febuxostat
    Intervention: Drug: LC350189
  • Placebo Comparator: Placebo
    Intervention: Drug: LC350189
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy male subjects between the ages of 20 and 50 years at screening
  2. 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.
  3. 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.
  4. 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
Sexes Eligible for Study: Male
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01361646
LG-GDCL001
Not Provided
Not Provided
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Principal Investigator: Kyung Sang Yu, MD, PhD Seoul National University Hospital
LG Life Sciences
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP