Acute Coronary SyndromePhase 1NCT01526577
Study of LC23-1306 in Healthy Male Subjects
A Phase 1 study testing LC23-1306 and Ticagrelor in people with Acute Coronary Syndrome, run by LG Life Sciences at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- LC23-1306 and Ticagrelor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Aug 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- LC23-1306, placebo, Ticagrelor
- Keywords
- phase1, healthy subjects, antiplatelet agent
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC23-1306Drug
Also called antiplatelet agent
LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
placeboDrug
LC23-1306 placebo
TicagrelorDrug
Ticagrelor 90mg
| Study group | Role | What they receive |
|---|---|---|
| LC23-1306 | Experimental | experimental drug Receives: Drug: LC23-1306 |
| placebo | Placebo comparator | LC23-1306 placebo Receives: Drug: placebo |
| Ticagrelor | Active comparator | active comparator Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of LC23-1306
Measured: 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.
Measured: 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
Measured: pre-dose, up to 1 day post-dose
Secondary outcomes (1)
AUC
Measured: pre-dose, up to 3 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526577
- Sponsor's protocol ID
- LG-PYCL001
- Other IDs
- LC23-1306
- Status last verified
- Aug 2013
- First submitted
- 20 Jan 2012
- Last updated
- 13 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01526577
- Acronym / sponsor ID
- LG-PYCL001
- Conditions
- Acute Coronary Syndrome
- Keywords
- phase1, healthy subjects, antiplatelet agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Posted 13 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LC23-1306 | Experimental | Drug: LC23-1306experimental drug |
| placebo | Placebo comparator | Drug: placeboLC23-1306 placebo |
| Ticagrelor | Active comparator | Drug: Ticagreloractive comparator |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC23-1306Also: antiplatelet agentLC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg | Drug | LC23-1306 |
| placeboLC23-1306 placebo | Drug | placebo |
| TicagrelorTicagrelor 90mg | Drug | Ticagrelor |
Primary outcome
Adverse Events of LC23-1306
Time frame: 7 days (plus or minus 1 day)
Pharmacodynamic Measurement
Time frame: 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
Time frame: pre-dose, up to 1 day post-dose
1 secondary outcome
AUC
Time frame: pre-dose, up to 3 days post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LC23-1306 and Ticagrelor in people with Acute Coronary Syndrome, run by LG Life Sciences at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events of LC23-1306 (time frame: 7 days (plus or minus 1 day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.