Acute Coronary Syndrome
Conditions
Keywords
phase1, healthy subjects, antiplatelet agent
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.
Interventions
DRUGLC23-1306
LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
DRUGplacebo
LC23-1306 placebo
DRUGTicagrelor
Ticagrelor 90mg
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events of LC23-1306 | 7 days (plus or minus 1 day) | — |
| Pharmacodynamic Measurement | 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study | 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 | pre-dose, up to 1 day post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC | pre-dose, up to 3 days post-dose |
Countries
South Korea
Participant flow
Recruitment details
* Recruitment location: Seoul University Hospital * Recruitment period: * Single dose study recruitment period: 12Mar2012 \ 18Sep2012 * Muti-dose study recruitment period: 02Dec2012 \ 05Aug2013
Pre-assignment details
The subjects were enrolled in single dose study and multiple study separately. The subject enrolled in single dose study was not allowed to be enrolled in multiple dose study.
Participants by arm
| Arm | Count |
|---|---|
| Single Dosing LC23-1306 Experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg | 49 |
| Single Dosing Placebo | 12 |
| Multiple Dosing LC23-1306 Experimental drug LC23-1306 100, 200, 400, 600mg | 33 |
| Multiple Dosing Placebo | 9 |
| Multiple Dosing Ticagrelor 90mg Active comparator | 10 |
| Total | 113 |
Baseline characteristics
| Characteristic | Single Dosing LC23-1306 | Single Dosing Placebo | Multiple Dosing LC23-1306 | Multiple Dosing Placebo | Multiple Dosing Ticagrelor 90mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous Age | 27 years STANDARD_DEVIATION 4 | 27 years STANDARD_DEVIATION 3 | 28 years STANDARD_DEVIATION 4 | 26 years STANDARD_DEVIATION 4 | 31 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 49 Participants | 12 Participants | 33 Participants | 9 Participants | 10 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 82 | 10 / 10 | 8 / 21 |
| serious Total, serious adverse events | 0 / 82 | 0 / 10 | 0 / 21 |
Outcome results
Primary
Adverse Events of LC23-1306
Time frame: 7 days (plus or minus 1 day)
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LC23-1306 | Pharmacodynamic Measurement | 70 percentage of platelet inhibition |
| Placebo | Pharmacodynamic Measurement | 30 percentage of platelet inhibition |
| Ticagrelor | Pharmacodynamic Measurement | 91.9 percentage of platelet inhibition |
Primary
Platelet Aggregation Test, Bleeding Test
Time frame: pre-dose, up to 1 day post-dose
Secondary
AUC
Time frame: pre-dose, up to 3 days post-dose