NCT01526577

Study of LC23-1306 in Healthy Male Subjects

A Dose Blocked-randomized, Double-blind, Active and Placebo Controlled, Single and Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	LC23-1306	LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
DRUG	placebo	LC23-1306 placebo
DRUG	Ticagrelor	Ticagrelor 90mg

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-11-01
• Completion: 2013-08-01
• First posted: 2012-02-06
• Last updated: 2018-08-13
• Results posted: 2018-08-13

Locations

1 site across 1 country: South Korea