Healthy SubjectsPhase 1NCT03942458
Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19
A Phase 1 study testing Vicagrel 6mg and Clopidogrel 75mg in people with Healthy Subjects and PK/PD, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, PK/PD
- What is being tested?
- Vicagrel 6mg and Clopidogrel 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2019to 3 Sep 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary signing of informed consent before the trial, and full understanding of the experimental content, process and possible adverse reactions;
- Subjects with ability and adherence to trial protocol;
- Subjects (including partners) voluntarily take effective contraceptive measures from screening to the last study drug administration within 6 months;
- Male and female aged 18-45,gender is unlimited (including 18 and 45 years old);
- Male Weight ≥50 kg, female Weight ≥ 45 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values);
- Physical examination, normal or abnormal vital signs have no clinical significance (reference range of vital signs: systolic blood pressure 90-150 mmHg, diastolic blood pressure 50-95 mmHg, pulse 50-110 beats/min, body temperature 35.5-37.2 °C);
- CYP2C19 rapid metabolizers (CYP2C19*1/*1), or intermediate metabolizers (CYP2C19*1/*2, CYP2C19*1/*3), or poor metabolizers (CYP2C19*2/*2, CYP2C19*2/* 3, CYP2C19*3/*3).
Who cannot join
- More than 5 cigarettes per day 3 months before the trial;
- History of allergies or allergies to the drug (two or more drugs or food allergies);
- History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Donate blood or massive blood loss (> 450 mL) within 3 months prior to formal screening;
- Take any drug that alters the activity of CYP450s within 28 days before the formal screening;
- Take any prescription, non-prescription, any vitamin or herbal medicine within 14 days of the formal screening;
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- Take special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks before the formal screening, or have strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- Taking inhibitors or inducers of the CYP3A4, P-gp or Bcrp Currently, such as itraconazole, ketoconazole or dronedarone;
- Recently there have been major changes in diet or exercise habits;
- Taking other research drugs or participating in clinical trials within 3 months before taking the study drug;
- History of dysphagia or any gastrointestinal disease affecting drug absorption;
- Have any disease that increases the risk of bleeding, such as acute gastritis, stomach and duodenal ulcers, thrombocytopenic purpura, hemophilia, and so on;
- ECG abnormalities have clinical significance;
- Female subjects are in lactation or have a positive of pregnancy test;
- Clinical laboratory abnormalities have clinical significance or other clinically significant abnormalities (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases);
- Infectious diseases (two pairs of hepatitis B, hepatitis C antibodies, HIV, Treponema pallidum antibodies) have positive results;
- Acute disease or concomitant medication from the screening to the study;
- Taking chocolate, any food or drink with caffeine or jaundice-rich within 48 hours before taking the study drug;
- Any alcoholic product or alcohol breath test positive within 24 hours before taking the study drug;
- Urine drug test (morphine, marijuana) is positive;
- The investigator believes that there are other factors who are not suitable for participating in the test.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients, divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism, 16 cases in each group. All groups of subjects were administered for 7 days in the first cycle, once a day (loading dose on the first day, maintenance dose on other days), and entering the 14-day washout period after the end of the first cycle. The second cycle was entered, and the second cycle was administered for 7 days, once a day (the first day was given a loading dose, and the other days were given a maintenance dose). Blood was collected before and after administration of D1, D7, D22, and D28, and PK/PD was measured.
- Conditions
- Healthy Subjects, PK/PD
- Being tested
- Vicagrel 6mg, Clopidogrel 75mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicagrel 6mgDrug
Vicagrel 24mg loading followed by 6mg/day for 6 days
Clopidogrel 75mgDrug
Clopidogrel 300mg loading followed by 75mg/day for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Vicagrel | Experimental | Vicagrel 24mg loading followed by 6mg/day for 6 days Receives: Drug: Vicagrel 6mg |
| Clopidogrel | Active comparator | Clopidogrel 300mg loading followed by 75mg/day for 6 days Receives: Drug: Clopidogrel 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
To evaluate the Peak Plasma Concentration (Cmax) after taking drugs
Measured: 1 day,7 days after taking drugs
Area under the plasma concentration versus time curve (AUC)
To evaluate the AUC after taking drugsl
Measured: 1 day,7 days after taking drugs
Time to maximum plasma concentration （Tmax）
To evaluate the Tmax after taking drugs
Measured: 1 day,7 days after taking drugs
terminal half-life （T1/2）
To evaluate the T1/2 after taking drugs
Measured: 1 day,7 days after taking drugs
inhibition of platelet aggregation
To evluate the inhibition of platelet aggregation assessed by Verifynow System after taking drugs
Measured: 1 day,7 days after taking drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start3 Apr 2019
- Primary completion28 Jun 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942458
- Sponsor's protocol ID
- VCP1-Ⅰ-04
- Status last verified
- Mar 2019
- First submitted
- 24 Apr 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19
- ClinicalTrials.gov ID
- NCT03942458
- Acronym / sponsor ID
- VCP1-Ⅰ-04
- Conditions
- Healthy Subjects, PK/PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 8 May 2019 (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 study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients, divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism, 16 cases in each group. All groups of subjects were administered for 7 days in the first cycle, once a day (loading dose on the first day, maintenance dose on other days), and entering the 14-day washout period after the end of the first cycle. The second cycle was entered, and the second cycle was administered for 7 days, once a day (the first day was given a loading dose, and the other days were given a maintenance dose). Blood was collected before and after administration of D1, D7, D22, and D28, and PK/PD was measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicagrel | Experimental | Drug: Vicagrel 6mgVicagrel 24mg loading followed by 6mg/day for 6 days |
| Clopidogrel | Active comparator | Drug: Clopidogrel 75mgClopidogrel 300mg loading followed by 75mg/day for 6 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Voluntary signing of informed consent before the trial, and full understanding of the experimental content, process and possible adverse reactions;
- Subjects with ability and adherence to trial protocol;
- Subjects (including partners) voluntarily take effective contraceptive measures from screening to the last study drug administration within 6 months;
- Male and female aged 18-45,gender is unlimited (including 18 and 45 years old);
- Male Weight ≥50 kg, female Weight ≥ 45 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values);
Key exclusion criteria (21 listed)
- More than 5 cigarettes per day 3 months before the trial;
- History of allergies or allergies to the drug (two or more drugs or food allergies);
- History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Donate blood or massive blood loss (> 450 mL) within 3 months prior to formal screening;
- Take any drug that alters the activity of CYP450s within 28 days before the formal screening;
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 6mgVicagrel 24mg loading followed by 6mg/day for 6 days | Drug | Vicagrel |
| Clopidogrel 75mgClopidogrel 300mg loading followed by 75mg/day for 6 days | Drug | Clopidogrel |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 1 day,7 days after taking drugs
To evaluate the Peak Plasma Concentration (Cmax) after taking drugs
Area under the plasma concentration versus time curve (AUC)
Time frame: 1 day,7 days after taking drugs
To evaluate the AUC after taking drugsl
Time to maximum plasma concentration （Tmax）
Time frame: 1 day,7 days after taking drugs
To evaluate the Tmax after taking drugs
terminal half-life （T1/2）
Time frame: 1 day,7 days after taking drugs
To evaluate the T1/2 after taking drugs
inhibition of platelet aggregation
Time frame: 1 day,7 days after taking drugs
To evluate the inhibition of platelet aggregation assessed by Verifynow System after taking drugs
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 19 Sep 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.
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 Vicagrel 6mg and Clopidogrel 75mg in people with Healthy Subjects and PK/PD, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
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 21 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 19 Sep 2019. 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 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?
Peak Plasma Concentration (Cmax) (time frame: 1 day,7 days after taking drugs). 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 19 Sep 2019.