Acute Coronary SyndromePhase 1NCT02419820
Dose-escalation, Repeated and Single Oral Dosing Study
A Phase 1 study testing APD791, Clopidogrel and Aspirin in people with Acute Coronary Syndrome, run by IlDong Pharmaceutical Co Ltd.
Trial summary
Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791 (Temanogrel) Co-administered with Aspirin and Clopidogrel. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- APD791, Clopidogrel and Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2016
- 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
- Men only
- 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
- 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
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
Show all 18Show fewer
- 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
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Temanogrel Co-administered With Aspirin and Clopidogrel
Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791 (Temanogrel) Co-administered with Aspirin and Clopidogrel.
Read the detailed description
- To investigate pharmacokinetic and pharmacodynamic characteristics of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subject. a person determined to be suitable for the purpose of this clinical trial by investigator with consideration for the age and the health status of a volunteer is selected
- Assess the safety of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subjects.
- Conditions
- Acute Coronary Syndrome
- Being tested
- APD791, Clopidogrel, Aspirin, Placebo for APD791
- 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.
APD791Drug
Also called Temanogrel
Temanogrel
ClopidogrelDrug
Also called Plavix
Clopidogrel
AspirinDrug
Also called Aspirin Protect
Aspirin
Placebo for APD791Drug
Also called Placebo for Temanogrel
Placebo for APD791
| Study group | Role | What they receive |
|---|---|---|
| APD791 10mg single dose | Experimental | APD791 10mg single dose Receives: Drug: APD791 |
| APD791 20mg single dose | Experimental | APD791 20mg single dose Receives: Drug: APD791 |
| APD791 40mg single dose | Experimental | APD791 40mg single dose Receives: Drug: APD791 |
| APD791 10mg | Experimental | APD791 10mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 20mg | Experimental | APD791 20mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 40mg | Experimental | APD791 40mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 80mg | Experimental | APD791 80mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 160mg | Experimental | APD791 160mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 240mg | Experimental | APD791 240mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 320mg | Experimental | APD791 320mg single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 Placebo | Placebo comparator | APD791 placebo for single dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo for APD791 |
| APD791 2mg MD | Experimental | APD791 2mg multiple dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 5mg MD | Experimental | APD791 5mg multiple dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 10mg MD | Experimental | APD791 10mg multiple dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 20mg MD | Experimental | APD791 placebo for multiple dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin |
| APD791 placebo MD | Placebo comparator | APD791 placebo for multiple dose + Aspirin + Clopidogrel Receives: Drug: APD791; Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo for APD791 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics-Cmax
Measured: Day1, Day2, Day3, Day4, Day 7
Pharmacokinetics-Tmax
Measured: Day1, Day2, Day3, Day4, Day 7
Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation
Measured: Day1, Day2, Day4, Day7, Day 8
Pharmacodynamics-change of serotonin-stimulated platelet aggregation
Measured: Day1, Day4, Day7
Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation
Measured: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
Secondary outcomes (5)
adverse event monitoring
Measured: up to post-study visit(8day±2)
physical examination
Measured: up to post-study visit(8day±2)
vital signs
Measured: up to post-study visit(8day±2)
ECG
Measured: up to post-study visit(8day±2)
laboratory test
Measured: up to post-study visit(8day±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
- Investigators
- Gyunseop Bae, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419820
- Sponsor's protocol ID
- ID-TMG-102
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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
- Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Temanogrel Co-administered With Aspirin and Clopidogrel
- ClinicalTrials.gov ID
- NCT02419820
- Acronym / sponsor ID
- ID-TMG-102
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 104 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Apr 2015 (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.
Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791 (Temanogrel) Co-administered with Aspirin and Clopidogrel.
Detailed description
- To investigate pharmacokinetic and pharmacodynamic characteristics of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subject. a person determined to be suitable for the purpose of this clinical trial by investigator with consideration for the age and the health status of a volunteer is selected
- Assess the safety of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| APD791 10mg single dose | Experimental | Drug: APD791APD791 10mg single dose |
| APD791 20mg single dose | Experimental | Drug: APD791APD791 20mg single dose |
| APD791 40mg single dose | Experimental | Drug: APD791APD791 40mg single dose |
| APD791 10mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 10mg single dose + Aspirin + Clopidogrel |
| APD791 20mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 20mg single dose + Aspirin + Clopidogrel |
| APD791 40mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 40mg single dose + Aspirin + Clopidogrel |
| APD791 80mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 80mg single dose + Aspirin + Clopidogrel |
| APD791 160mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 160mg single dose + Aspirin + Clopidogrel |
| APD791 240mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 240mg single dose + Aspirin + Clopidogrel |
| APD791 320mg | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 320mg single dose + Aspirin + Clopidogrel |
| APD791 Placebo | Placebo comparator | Drug: APD791, Drug: Clopidogrel, Drug: Aspirin, Drug: Placebo for APD791APD791 placebo for single dose + Aspirin + Clopidogrel |
| APD791 2mg MD | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 2mg multiple dose + Aspirin + Clopidogrel |
| APD791 5mg MD | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 5mg multiple dose + Aspirin + Clopidogrel |
| APD791 10mg MD | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 10mg multiple dose + Aspirin + Clopidogrel |
| APD791 20mg MD | Experimental | Drug: APD791, Drug: Clopidogrel, Drug: AspirinAPD791 placebo for multiple dose + Aspirin + Clopidogrel |
| APD791 placebo MD | Placebo comparator | Drug: APD791, Drug: Clopidogrel, Drug: Aspirin, Drug: Placebo for APD791APD791 placebo for multiple dose + Aspirin + Clopidogrel |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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, 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
- a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
Key exclusion criteria (18 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 |
|---|---|---|
| APD791Also: TemanogrelTemanogrel | Drug | APD791 10mg, APD791 10mg MD, APD791 10mg single dose, APD791 160mg, APD791 20mg, APD791 20mg MD, APD791 20mg single dose, APD791 240mg, APD791 2mg MD, APD791 320mg, APD791 40mg, APD791 40mg single dose, APD791 5mg MD, APD791 80mg, APD791 Placebo, APD791 placebo MD |
| ClopidogrelAlso: PlavixClopidogrel | Drug | APD791 10mg, APD791 10mg MD, APD791 160mg, APD791 20mg, APD791 20mg MD, APD791 240mg, APD791 2mg MD, APD791 320mg, APD791 40mg, APD791 5mg MD, APD791 80mg, APD791 Placebo, APD791 placebo MD |
| AspirinAlso: Aspirin ProtectAspirin | Drug | APD791 10mg, APD791 10mg MD, APD791 160mg, APD791 20mg, APD791 20mg MD, APD791 240mg, APD791 2mg MD, APD791 320mg, APD791 40mg, APD791 5mg MD, APD791 80mg, APD791 Placebo, APD791 placebo MD |
| Placebo for APD791Also: Placebo for TemanogrelPlacebo for APD791 | Drug | APD791 Placebo, APD791 placebo MD |
Primary outcome
Pharmacokinetics-Cmax
Time frame: Day1, Day2, Day3, Day4, Day 7
Pharmacokinetics-Tmax
Time frame: Day1, Day2, Day3, Day4, Day 7
Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation
Time frame: Day1, Day2, Day4, Day7, Day 8
Pharmacodynamics-change of serotonin-stimulated platelet aggregation
Time frame: Day1, Day4, Day7
Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation
Time frame: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
5 secondary outcomes
adverse event monitoring
Time frame: up to post-study visit(8day±2)
physical examination
Time frame: up to post-study visit(8day±2)
vital signs
Time frame: up to post-study visit(8day±2)
ECG
Time frame: up to post-study visit(8day±2)
laboratory test
Time frame: up to post-study visit(8day±2)
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.
Gyunseop Bae, M.D. principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APD791, Clopidogrel and Aspirin 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 6 inclusion and 18 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?
Pharmacokinetics-Cmax (time frame: Day1, Day2, Day3, Day4, Day 7). The study lists 5 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 15 Feb 2019.