Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

Gout Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361646
• Other study ID #: LG-GDCL001
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2011
• Last updated: June 10, 2013
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• LC350189
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of LC350189		7 days(plus or minus 1 day)	Yes
Secondary	Cmax		3 days	No
Secondary	AUC		3days	No
Secondary	Tmax		3days	No