Study of LC23-1306 in Healthy Male Subjects

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Acute Coronary Syndrome

Treatments: Drug: Ticagrelor; Drug: placebo; Drug: LC23-1306

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526577

LG-PYCL001

LC23-1306 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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113 participants in 3 patient groups, including a placebo group

LC23-1306

Experimental group

Description:

experimental drug

Treatment:

Drug: LC23-1306

placebo

Placebo Comparator group

Description:

LC23-1306 placebo

Treatment:

Drug: placebo

Ticagrelor

Active Comparator group

Description:

active comparator

Treatment:

Drug: Ticagrelor