Acute Coronary SyndromePhase 1TG1CNCT02034292
Safety Study of APD-791 With Aspirin and/or Clopidogrel
A Phase 1 study testing Clopidogrel, Aspirin and APD791 in people with Acute Coronary Syndrome, run by IlDong Pharmaceutical Co Ltd.
Trial summary
Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Clopidogrel, Aspirin and APD791
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Mar 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a healthy adult between 20 and 45 years old at the time of visit for screening
- a person who is able to give written consent
- a person between 50 and 85 kg at the time of visit for screening
- a woman who is negative on a serum hCG test at the time of visit and the day before a trial, and who is not nursing
- a woman who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, or who had a contraceptive operation no later than 120 days before visit for screening, or who is menopausal
- a man who had a contraceptive operation no later than 120 days before visit for screening, or who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, and also agree not to donate sperm
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- a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
- a person whose vital signs were in the normal range at the time of visit for screening, or who is medically determined not to be clinically significant by an investigator
- a person who voluntarily decides to participate in this clinical trial and gives written consent on strict clinical trial compliance
- a person whose blood can be collected during a study period with visit for monitoring
Who cannot join
- a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
- a person with the medical history of gastrointestinal diseases(e.g. Crohn's disease, ulcerative colitis, etc.) or surgery(excluding uncomplicated appendectomy or herniotomy) affecting the absorption of a clinical trial drug
- a person with the medical history of blood coagulation disorder or hemorrhagic diseases, or with clinically significant abnormal findings decided by a investigator on blood coagulation test at the time of screening
- a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
- a person with the medical history of epilepsy or convulsion
- a person with the medical history of internal organ transplant
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- a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
- a person with the medical history of clinically significant new diseases within 30 days from the time of visit for screening according to investigator's decision
- a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
- a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
- a person with the medical history of alcohol abuse within two years from the time of visit for screening
- a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
- a person who donated whole blood within 60 days or constituents of blood within 30 days, or received a blood transfusion within 30 days from the time of visit for screening
- a person taking other clinical trial drugs within 90 days from the time of visit for screening
- a person taking a prescription drug within 30 days, or a contraindicated drug or oriental medicine within 14 days from the time of visit for screening
- a person with a positive reaction to a serum test(hepatitis B test, hepatitis C test, HIV test, syphilis test)
- a person with hepatic enzymes(AST, ALT) more than 2.5 times of the reference upper limit(UNL) or total bilirubin more than 1.5 times of the reference upper limit(UNL) or creatinine more than 1.25 times of the reference upper limit(UNL)
- a person expected to be hard to complete a clinical trial due to physical or mental status according to investigator's medical decision at the time of visit for screening
- a person decided to be inappropriate to participate in this clinical trial according to investigator's medical decision on the result of laboratory tests, such as complete blood cell count, general chemical test, clinicochemical urinalysis, and physical examination, vital signs, ECG, other tests excluding exclusion criteria 17 items conducted before subject selection for a clinical trial
About this study
Official title: Phase I Study to Assess the Safety of APD-791 When Co-administered With Aspirin
Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Clopidogrel, Aspirin, APD791, Placebo
- 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.
ClopidogrelDrug
AspirinDrug
APD791Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 10mg MD | Experimental | APD791 10mg Multiple dose and Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| 20mg MD | Experimental | APD791 20mg Multiple dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| 40mg MD | Experimental | APD791 40mg Multiple dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| 60mg MD | Experimental | APD791 60mg Multiple dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| Placebo MD | Placebo comparator | Placebo for Multiple dose group Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| 120mg SD | Experimental | APD791 120mg Single dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| 240mg SD | Experimental | APD791 240mg Single dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| 320mg SD | Experimental | APD791 320mg Single dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: APD791 |
| Placebo SD | Placebo comparator | Placebo for Single dose Receives: Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects
Adverse reaction monitoring for subjective or objective symptoms Physical examination Vital signs 12-electrode ECG Laboratory tests
Measured: safety review will be conducted at every end of dosing (about every 2 or 3 weeks)
Secondary outcomes (2)
Pharmacokinetic characteristic evaluation variable
Non-compartmental analysis is conducted by using APD791 and its metabolite, M1 and M2 and the following pharmacokinetic evaluation variables are calculated.
Cmax0-12, Cmax,ss (Day 7 only), Cmin,ss (Day 7 only), tmax0-12, tmax,ss (Day 7 only), λz, t1/2β, AUC0-12 (Day 1 only), AUCinf, Accumulation index, CL/F, MRT, Vz/F
Measured: After last patient last visit. About 8month later since start of the study.
Pharmacodynamic characteristic evaluation variable
Pharmacodynam1) % inhibition of serotonin-stimulated platelet aggregation 2) Change in % inhibition of serotonin-stimulated platelet aggregation 3) % inhibition of TRAP-induced platelet aggregation ic characteristic evaluation variable
Measured: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Sponsor Decision
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034292
- Sponsor's protocol ID
- ID-TG1C-1301
- Acronym
- TG1C
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Assess the Safety of APD-791 When Co-administered With Aspirin
- ClinicalTrials.gov ID
- NCT02034292
- Acronym / sponsor ID
- TG1C / ID-TG1C-1301
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- Feb 2014 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Jan 2014 (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.
Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 10mg MD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 10mg Multiple dose and |
| 20mg MD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 20mg Multiple dose |
| 40mg MD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 40mg Multiple dose |
| 60mg MD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 60mg Multiple dose |
| Placebo MD | Placebo comparator | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791Placebo for Multiple dose group |
| 120mg SD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 120mg Single dose |
| 240mg SD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 240mg Single dose |
| 320mg SD | Experimental | Drug: Clopidogrel, Drug: Aspirin, Drug: APD791APD791 320mg Single dose |
| Placebo SD | Placebo comparator | Drug: Clopidogrel, Drug: Aspirin, Drug: PlaceboPlacebo for Single dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- a healthy adult between 20 and 45 years old at the time of visit for screening
- a person who is able to give written consent
- a person between 50 and 85 kg at the time of visit for screening
- a woman who is negative on a serum hCG test at the time of visit and the day before a trial, and who is not nursing
- a woman who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, or who had a contraceptive operation no later than 120 days before visit for screening, or who is menopausal
Key exclusion criteria (19 listed)
- a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
- a person with the medical history of gastrointestinal diseases(e.g. Crohn's disease, ulcerative colitis, etc.) or surgery(excluding uncomplicated appendectomy or herniotomy) affecting the absorption of a clinical trial drug
- a person with the medical history of blood coagulation disorder or hemorrhagic diseases, or with clinically significant abnormal findings decided by a investigator on blood coagulation test at the time of screening
- a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
- a person with the medical history of epilepsy or convulsion
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 |
|---|---|---|
| Clopidogrel | Drug | 10mg MD, 120mg SD, 20mg MD, 240mg SD, 320mg SD, 40mg MD, 60mg MD, Placebo MD, Placebo SD |
| Aspirin | Drug | 10mg MD, 120mg SD, 20mg MD, 240mg SD, 320mg SD, 40mg MD, 60mg MD, Placebo MD, Placebo SD |
| APD791 | Drug | 10mg MD, 120mg SD, 20mg MD, 240mg SD, 320mg SD, 40mg MD, 60mg MD, Placebo MD |
| Placebo | Drug | Placebo SD |
Primary outcome
To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects
Time frame: safety review will be conducted at every end of dosing (about every 2 or 3 weeks)
Adverse reaction monitoring for subjective or objective symptoms Physical examination Vital signs 12-electrode ECG Laboratory tests
2 secondary outcomes
Pharmacokinetic characteristic evaluation variable
Time frame: After last patient last visit. About 8month later since start of the study.
Pharmacodynamic characteristic evaluation variable
Time frame: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clopidogrel, Aspirin and APD791 in people with Acute Coronary Syndrome, run by IlDong Pharmaceutical Co Ltd.
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 10 inclusion and 19 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: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects (time frame: safety review will be conducted at every end of dosing (about every 2 or 3 weeks)). 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 15 Feb 2019.