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Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01361646
First received: May 19, 2011
Last updated: June 10, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperuricemia
Gout
 Drug: LC350189
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Gout
U.S. FDA Resources

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Adverse events of LC350189 [ Time Frame: 7 days(plus or minus 1 day) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: 3days ] [ Designated as safety issue: No ]
  • Tmax [ Time Frame: 3days ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LC350189 Drug: LC350189
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
Active Comparator: Febuxostat Drug: LC350189
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
Placebo Comparator: Placebo Drug: LC350189
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361646

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Kyung Sang Yu, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01361646     History of Changes
Other Study ID Numbers: LG-GDCL001
Study First Received: May 19, 2011
Last Updated: June 10, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013