Study of LC23-1306 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: LC23-1306; Drug: placebo; Drug: Ticagrelor

• Registration Number: NCT01526577
• Lead Sponsor: LG Life Sciences

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 available

Study Timeline

• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Study Start: 2012-03
• Primary Completion: 2012-11
• Status Verified: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2015-05-20
• Results First Submitted QC: 2017-11-03
• Last Update Submitted: 2017-11-03
• Results First Posted: 2018-08-13
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 113

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LC23-1306	LC23-1306	experimental drug
placebo	placebo	LC23-1306 placebo
Ticagrelor	Ticagrelor	active comparator

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic Measurement	1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study	Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test.; \* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section.
Platelet Aggregation Test, Bleeding Test	pre-dose, up to 1 day post-dose
Adverse Events of LC23-1306	7 days (plus or minus 1 day)

Secondary Outcome Measures

Name	Time	Method
AUC	pre-dose, up to 3 days post-dose

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of