Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LC23-1306 | Other Identifier | LGLS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC23-1306 | Experimental | experimental drug |
|
| placebo | Placebo Comparator | LC23-1306 placebo |
|
| Ticagrelor | Active Comparator | active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC23-1306 | Drug | LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | pre-dose, up to 3 days post-dose |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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.
Recruitment location: Seoul University Hospital
Recruitment period:
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Dosing LC23-1306 | experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg |
| FG001 | Single Dosing Placebo | |
| FG002 | Multiple Dosing LC23-1306 | LC23-1306 100, 200, 400, 600mg |
| FG003 | Multiple Dosing Placebo | |
| FG004 | Multiple Dosing Ticagrelor 90mg | Active comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Dosing LC23-1306 | Experimental drug LC23-1306 10, 30, 100, 200, 400, 600 mg |
| BG001 | Single Dosing Placebo | |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events of LC23-1306 | Not Posted | 7 days (plus or minus 1 day) | Participants | ||||||||||||
| 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. | Posted | Number | percentage of platelet inhibition | 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LC23-1306 | Test drug. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and so on. | Gastrointestinal disorders | One of the related AE. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dong Yeop Shin | LG Life Sciences | 82 2 6924 3114 | dongyeopshin@lgls.com |
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010975 | Platelet Aggregation Inhibitors |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | LC23-1306 placebo |
|
| Ticagrelor | Drug | Ticagrelor 90mg |
|
| Multiple Dosing LC23-1306 |
Experimental drug LC23-1306 100, 200, 400, 600mg |
| BG003 | Multiple Dosing Placebo |
| BG004 | Multiple Dosing Ticagrelor 90mg | Active comparator |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | AUC | Not Posted | pre-dose, up to 3 days post-dose | Participants |
| Primary | Platelet Aggregation Test, Bleeding Test | Not Posted | pre-dose, up to 1 day post-dose | Participants |
| 0 |
| 82 |
| 43 |
| 82 |
| EG001 | Ticagrelar | Active comparator | 0 | 10 | 10 | 10 |
| EG002 | Placebo | 0 | 21 | 8 | 21 |
Not provided
Not provided
| D000241 |
| Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |