Study of LC23-1306 in Healthy Male Subjects

LG Life Sciences113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

113

Conditions

Acute Coronary Syndrome

Interventions

LC23-1306DRUG

LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg

placeboDRUG

LC23-1306 placebo

TicagrelorDRUG

Ticagrelor 90mg

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse Events of LC23-1306

Time frame: 7 days (plus or minus 1 day)

Pharmacodynamic Measurement

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.

Time frame: 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study

Platelet Aggregation Test, Bleeding Test

Time frame: pre-dose, up to 1 day post-dose

Secondary Outcomes

AUC

Time frame: pre-dose, up to 3 days post-dose

Data from ClinicalTrials.gov

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