Acute Coronary SyndromePhase 1YH14659NCT01422109
Comparative Pharmacokinetics of YH14659
A Phase 1 study testing YH14659 and clopidogrel & aspirin in people with Acute Coronary Syndrome, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- YH14659 and clopidogrel & aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
- Healthy male volunteers of aged between 20 years to 55 years
- Have standard weight of ≤ ±20% based on Broca index* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
- Have no history of neither congenital nor chronic disease
- Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
- Eligible subjects with acceptable medical history, physical examination laboratory tests, ECG during screening period
Who cannot join
- Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
- Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
- Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
- Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
- Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
- Have the following abnormal findings on diagnosis;
Show all 16Show fewer
- have AST or ALT > 1.25 times of normal upper limit
- have total bilirubin > 1.5 times of normal upper limit
- have higher PT, aPPT, BT than normal range
- have PLT below 150,000 or above 350,000
- Have been drug abuse, excessive caffeine (> 5 cups/day), heavy smoking (>10 cigarettes/day), continuous alcohol intake (> 30g/day) or have drunk within the last 7 days prior to the first administration
- Have been on a diet that can affect absorption, distribution, metabolism and excretion of the drug (especially grapefruit juice 7 days prior to the first administration)
- Donated blood within 60 days prior to the first administration
- Participated in any other clinical trials within 60 days prior to the first administration
- Have used any drug which is thought to affect this study by principal investigator 10 days prior to the first administration
- Subject who is judged to be ineligible by principal investigator or sub-investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers
The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
- Conditions
- Acute Coronary Syndrome
- Being tested
- YH14659, clopidogrel & aspirin
- Keywords
- YH14659, Aspirin, Clopidogrel, Yuhan
- 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.
YH14659Drug
YH14659 capsule by oral
clopidogrel & aspirinDrug
clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: YH14659 |
| Group B | Active comparator | Not described Receives: Drug: clopidogrel & aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration(Cmax) of clopidogrel
Measured: 14 days
Area under the time-concentration curve to last concentration(AUCt) of clopidogrel
Measured: 14 days
Maximum plasma concentration(Cmax) of acetylsalicylic acid
Measured: 14 days
Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid
Measured: 14 days
Secondary outcomes (2)
Cmax of salicylic acid, the major active metabolite of aspirin
Measured: 14 days
AUCt of salicylic acid, the major active metabolite of aspirin
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Gook Shin, MD, PhD., Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422109
- Sponsor's protocol ID
- YH14659-101
- Acronym
- YH14659
- Status last verified
- Jan 2012
- First submitted
- 16 Aug 2011
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01422109
- Acronym / sponsor ID
- YH14659 / YH14659-101
- Conditions
- Acute Coronary Syndrome
- Keywords
- YH14659, Aspirin, Clopidogrel, Yuhan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: YH14659 |
| Group B | Active comparator | Drug: clopidogrel & aspirin |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
- Healthy male volunteers of aged between 20 years to 55 years
- Have standard weight of ≤ ±20% based on Broca index* (Broca index: ideal weight(kg) = (height(cm)-100) x 0.9)
- Have no history of neither congenital nor chronic disease
- Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
Key exclusion criteria (16 listed)
- Received any drug that induce or/and inhibit drug metabolizing enzyme such as barbital within the last 28 days prior to the first administration
- Shown symptoms doubtful as an acute disease within the last 28 days prior to the first administration
- Have signs of bleeding symptoms or/and history of disease such as: gum bleeding, hard to control hemorrhage, easily suffer from bruise, and etc.
- Have disease that can affect absorption, distribution, metabolism and excretion of the drug such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer, hepatic disorders, and gastrointestinal tract surgery except appendectomy
- Have a known allergy(except mild allergic rhinitis which does not require treatment) or hypersensitivity to drugs
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 |
|---|---|---|
| YH14659YH14659 capsule by oral | Drug | Group A |
| clopidogrel & aspirinclopidogrel tablet(75mg) + aspirin capsules(100mg) by oral | Drug | Group B |
Primary outcome
Maximum plasma concentration(Cmax) of clopidogrel
Time frame: 14 days
Area under the time-concentration curve to last concentration(AUCt) of clopidogrel
Time frame: 14 days
Maximum plasma concentration(Cmax) of acetylsalicylic acid
Time frame: 14 days
Area under the time-concentration curve to last concentration(AUCt) of acetylsalicylic acid
Time frame: 14 days
2 secondary outcomes
Cmax of salicylic acid, the major active metabolite of aspirin
Time frame: 14 days
AUCt of salicylic acid, the major active metabolite of aspirin
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
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.
Jae-Gook Shin, MD, PhD. principal investigator
Inje University
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 YH14659 and clopidogrel & aspirin in people with Acute Coronary Syndrome, run by Yuhan Corporation 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 6 inclusion and 16 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 9 Jan 2012. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration(Cmax) of clopidogrel (time frame: 14 days). The study lists 4 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 9 Jan 2012.