Acute Coronary SyndromePhase 1NCT05162053
PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers
A Phase 1 study testing vicagrel Capsules and Clopidogrel Tablets in people with Acute Coronary Syndrome, run by Jiangsu vcare pharmaceutical technology co., LTD at 3 sites in 2 countries.
Trial summary
This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- vicagrel Capsules and Clopidogrel Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Dec 2021to 3 Nov 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
- Able to complete the study in compliance with the protocol;
- Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 90 days after the last dose of study drug (see Appendix 5 for details);
- Male and female subjects between the ages of 18 and 65 years, inclusive;
- At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 18-32 kg/m2, inclusive;
- With normal or clinically insignificant abnormal results of physical examination and vital signs test;
- Subjects will be assigned into the group according to the CYP2C19 genotype: the first group of ultra-rapid metabolizers (CYP2C19*17/*17); the second group of rapid metabolizers (CYP2C19*1/*17); the third group of normal metabolizers (CYP2C19*1/*1); the fourth group of intermediate metabolizers (CYP2C19*1/*2, *1/*3, *2/*17, *3/*17); and the fifth group of poor metabolizers (CYP2C19*2/*2, *2/*3, *3/*3).。
Who cannot join
- More than 5 cigarettes per day on average within 3 months before the study;
- History of sensitivity to drugs similar to the study drug or have high sensitivity to clopidogrel, allergic constitution (e.g. allergy to various drugs and foods);
- History of drug abuse, drug use, alcohol abuse (14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines);
- Donation or loss of a significant volume of blood (> 450 mL) within 56 days prior to screening;
- Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;
- Consumption of any special diet (such as grapefruit, pitaya, mango, pomelo, etc.) or subjects have engaged strenuous exercise or any other factors affecting drug absorption, distribution, metabolism and excretion within 14 days prior to receiving study drug;
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- Intake of any drug which Have taken strong inhibitors and/or inducers of liver metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5) within 28 days before the first medication, and strong inhibitors of liver metabolic enzymes such as: ciprofloxacin, clopidogrel, Itraconazole, ketoconazole, ritonavir, troleandomycin, etc., strong inducers of liver metabolism enzymes such as: rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc.(For details see Appendix 6);
- Recent major changes in diet or exercise habits;
- Use of an investigational drug or product, or participation in a drug research study within 30 days (or 5 half-lives) prior to receiving study drug;
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
- Suffering from any diseases that may increase the risk of bleeding, such as hemorrhoids, acute gastritis, stomach and duodenal ulcers, Thrombocytopenic Purpura and hemophilia, etc;
- Family history of coagulation or bleeding disorders (e.g., hemophilia)/symptoms (e.g., vomiting blood, black stools, severe or recurrent nosebleeds, coughing up blood, significant hematuria, or intracranial hemorrhage) or suspected vascular malformations, such as aneurysms or early onset strokes, in the individual or in their immediate family;
- A clinically significant 12-lead ECG abnormality;
- Positive test results of blood pregnancy or subject is lactating for female subjects;
- Any clinically significant abnormalities/findings in laboratory tests, or any clinically significant disease including but not limited to gastrointestinal, renal, hepatic, neurological system, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases;
- Positive test results for viral hepatitis (including hepatitis B and C), HIV antibody or syphilis antibody;
- Acute illness or concomitant medication from screening to the first dosing of study medication;
- Consumption of chocolate or any food or beverages containing caffeine or (rich containing) xanthine within 48 h prior to receiving the first dosing of study medication;
- Consumption of any product containing alcohol within 24 h prior to receiving the first dosing of study medication, or positive results from a screen for alcohol;
- Positive results from a screen for urine drug test (Morphine, marijuana);
- Subjects were vaccinated within 4 weeks prior to screening, or planned to be vaccinated during the trial;
- Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study (For ultra-rapid metabolizers and rapid metabolizers, investigators may consider at their discretion).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Altasciences, Kansas City
Kansas City, Missouri, 66212
Altasciences Clinical, Los Angeles
Los Angeles, California, 90630
China1 site
Phase I Clinical Research Center of The First Hospital of Jilin University
Changchun, Jilin, 130021
About this study
Official title: A Phase 1, Open-label, Randomized, Multiple-dose, Crossover Pharmacokinetic/Pharmacodynamic Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Phenotypes
This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers
- Conditions
- Acute Coronary Syndrome
- Being tested
- vicagrel Capsules, Clopidogrel Tablets
- 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.
vicagrel CapsulesDrug
Oral administration for 7 days under fasting
Clopidogrel TabletsDrug
Also called PLAVIX
Oral administration for 7 days under fasting
| Study group | Role | What they receive |
|---|---|---|
| Ultra-rapid metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles Receives: Drug: vicagrel Capsules; Drug: Clopidogrel Tablets |
| Rapid metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles Receives: Drug: vicagrel Capsules; Drug: Clopidogrel Tablets |
| Normal metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles Receives: Drug: vicagrel Capsules; Drug: Clopidogrel Tablets |
| Intermediate metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles Receives: Drug: vicagrel Capsules; Drug: Clopidogrel Tablets |
| Poor metabolizers group | Experimental | A 7-day cross-dosing of vicagrel and clopidogrel between two cycles Receives: Drug: vicagrel Capsules; Drug: Clopidogrel Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel
To compare IPA following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
Measured: Day1-Day31
Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel
To compare PRI following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
Measured: Day1-Day31
maximum plasma concentration (Cmax)
To compare Cmax following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
Measured: Day1-Day31
Area under the curve over a dosing interval(AUC0-tau)
To compare AUC0-tau following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
Measured: Day1-Day31
Secondary outcomes (1)
Assess the safety and tolerability of multiple doses of both drugs in each CYP2C19 phenotype group.
Measured: Day1-Day31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start9 Dec 2021
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multiple-center, open-label, randomized, multiple-dose, crossover design
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Principal investigator, Phase I Clinical Research Center of The First Hospital of Jilin UniversityYoungjun David Kim, MD, Principal investigator, Altasciences Clinical, Los AngelesMartin Kankam, MD, Principal investigator, Altasciences, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162053
- Sponsor's protocol ID
- VCP1-Ⅰ-06
- Status last verified
- Nov 2023
- First submitted
- 14 Dec 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Multiple-dose, Crossover Pharmacokinetic/Pharmacodynamic Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Phenotypes
- ClinicalTrials.gov ID
- NCT05162053
- Acronym / sponsor ID
- VCP1-Ⅰ-06
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- 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.
This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Multiple-center, open-label, randomized, multiple-dose, crossover design
| Arm | Type | Receives |
|---|---|---|
| Ultra-rapid metabolizers group | Experimental | Drug: vicagrel Capsules, Drug: Clopidogrel TabletsA 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
| Rapid metabolizers group | Experimental | Drug: vicagrel Capsules, Drug: Clopidogrel TabletsA 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
| Normal metabolizers group | Experimental | Drug: vicagrel Capsules, Drug: Clopidogrel TabletsA 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
| Intermediate metabolizers group | Experimental | Drug: vicagrel Capsules, Drug: Clopidogrel TabletsA 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
| Poor metabolizers group | Experimental | Drug: vicagrel Capsules, Drug: Clopidogrel TabletsA 7-day cross-dosing of vicagrel and clopidogrel between two cycles |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
- Able to complete the study in compliance with the protocol;
- Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 90 days after the last dose of study drug (see Appendix 5 for details);
- Male and female subjects between the ages of 18 and 65 years, inclusive;
- At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 18-32 kg/m2, inclusive;
Key exclusion criteria (22 listed)
- More than 5 cigarettes per day on average within 3 months before the study;
- History of sensitivity to drugs similar to the study drug or have high sensitivity to clopidogrel, allergic constitution (e.g. allergy to various drugs and foods);
- History of drug abuse, drug use, alcohol abuse (14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines);
- Donation or loss of a significant volume of blood (> 450 mL) within 56 days prior to screening;
- Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;
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 |
|---|---|---|
| vicagrel CapsulesOral administration for 7 days under fasting | Drug | Intermediate metabolizers group, Normal metabolizers group, Poor metabolizers group, Rapid metabolizers group, Ultra-rapid metabolizers group |
| Clopidogrel TabletsAlso: PLAVIXOral administration for 7 days under fasting | Drug | Intermediate metabolizers group, Normal metabolizers group, Poor metabolizers group, Rapid metabolizers group, Ultra-rapid metabolizers group |
Primary outcome
Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel
Time frame: Day1-Day31
To compare IPA following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel
Time frame: Day1-Day31
To compare PRI following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
maximum plasma concentration (Cmax)
Time frame: Day1-Day31
To compare Cmax following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
Area under the curve over a dosing interval(AUC0-tau)
Time frame: Day1-Day31
To compare AUC0-tau following multiple doses of vicagrel and/or clopidogrel in healthy subjects with different CYP2C19 phenotypes.
1 secondary outcome
Assess the safety and tolerability of multiple doses of both drugs in each CYP2C19 phenotype group.
Time frame: Day1-Day31
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 3 Nov 2023.
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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.
Yanhua Ding principal investigator
Phase I Clinical Research Center of The First Hospital of Jilin University
Youngjun David Kim, MD principal investigator
Altasciences Clinical, Los Angeles
Martin Kankam, MD principal investigator
Altasciences, Kansas City
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vicagrel Capsules and Clopidogrel Tablets in people with Acute Coronary Syndrome, run by Jiangsu vcare pharmaceutical technology co., LTD at 3 sites in 2 countries.
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 7 inclusion and 22 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, China. 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?
Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with either vicagrel or clopidogrel (time frame: Day1-Day31). 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 3 Nov 2023.