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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
  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 (Participant, Investigator)
Primary Purpose: Treatment

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) ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: 3 days ]
  • AUC [ Time Frame: 3days ]
  • Tmax [ Time Frame: 3days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01361646     History of Changes
Other Study ID Numbers: LG-GDCL001
First Submitted: May 19, 2011
First Posted: May 27, 2011
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes