Study of LC23-1306 in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: LC23-1306
* Drug: placebo
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 20 and 50 years at screening 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. 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. 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC23-1306<br>experimental drug | Drug: LC23-1306<br>* LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg<br>* Other names: antiplatelet agent;|
| Placebo Comparator: placebo<br>LC23-1306 placebo | Drug: placebo<br>* LC23-1306 placebo<br>|
| Active Comparator: Ticagrelor<br>active comparator | Drug: Ticagrelor<br>* Ticagrelor 90mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events of LC23-1306 |  | 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. | 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 |  | pre-dose, up to 1 day post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | pre-dose, up to 3 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase1, healthy subjects, antiplatelet agent