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Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

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: NCT01361646
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 27, 2011
Last Update Posted Date June 11, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
Adverse events of LC350189 [ Time Frame: 7 days(plus or minus 1 day) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01361646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
  • Cmax [ Time Frame: 3 days ]
  • AUC [ Time Frame: 3days ]
  • Tmax [ Time Frame: 3days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperuricemia
  • Gout
Intervention  ICMJE Drug: LC350189
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
Study Arms  ICMJE
  • Experimental: LC350189
    Intervention: Drug: LC350189
  • Active Comparator: Febuxostat
    Intervention: Drug: LC350189
  • Placebo Comparator: Placebo
    Intervention: Drug: LC350189
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2013)
129
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2011)
72
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01361646
Other Study ID Numbers  ICMJE LG-GDCL001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LG Life Sciences
Study Sponsor  ICMJE LG Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung Sang Yu, MD, PhD Seoul National University Hospital
PRS Account LG Life Sciences
Verification Date June 2013

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