Back to resultsStudy of LC23-1306 in Healthy Male Subjects
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LC23-1306
placebo
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring phase1, healthy subjects, antiplatelet agent
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
LC23-1306
placebo
Ticagrelor
Arm Description
experimental drug
LC23-1306 placebo
active comparator
Outcomes
Primary Outcome Measures
Adverse Events of LC23-1306
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.
Platelet Aggregation Test, Bleeding Test
Secondary Outcome Measures
AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01526577
Brief Title
Study of LC23-1306 in Healthy Male Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
phase1, healthy subjects, antiplatelet agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LC23-1306
Arm Type
Experimental
Arm Description
experimental drug
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
LC23-1306 placebo
Arm Title
Ticagrelor
Arm Type
Active Comparator
Arm Description
active comparator
Intervention Type
Drug
Intervention Name(s)
LC23-1306
Other Intervention Name(s)
antiplatelet agent
Intervention Description
LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
LC23-1306 placebo
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor 90mg
Primary Outcome Measure Information:
Title
Adverse Events of LC23-1306
Time Frame
7 days (plus or minus 1 day)
Title
Pharmacodynamic Measurement
Description
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
Title
Platelet Aggregation Test, Bleeding Test
Time Frame
pre-dose, up to 1 day post-dose
Secondary Outcome Measure Information:
Title
AUC
Time Frame
pre-dose, up to 3 days post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of LC23-1306 in Healthy Male Subjects
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