Study of LC23-1306 in Healthy Male Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-08-31

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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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LC23-1306

experimental drug

Group Type EXPERIMENTAL

LC23-1306

Intervention Type DRUG

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

placebo

LC23-1306 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

LC23-1306 placebo

Ticagrelor

active comparator

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Ticagrelor 90mg

Interventions

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LC23-1306

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

Intervention Type DRUG

placebo

LC23-1306 placebo

Intervention Type DRUG

Ticagrelor

Ticagrelor 90mg

Intervention Type DRUG

Other Intervention Names

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antiplatelet agent

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes