Acute Coronary SyndromePhase 1NCT04919551
A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult Subjects
A Phase 1 study testing vicagrel in people with Acute Coronary Syndrome, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This clinical study will adopt a randomized, open-label, single-dose, 3-cycle, 3-way crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules under fasted and fed conditions in health subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- vicagrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2021to 20 Oct 2021
- 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 ARs;
- Able to complete the study according to the protocol;
- Subjects (and their partners) are willing to take effective contraceptive measures from screening to 6 month after the last dose of the IMPs. See Appendix 5 for specific contraceptive measures;
- Male and female subjects aged 18 to 45 years (inclusive);
- Male weight ≥50 kg, female weight ≥ 45 kg. Body mass index (BMI) = body weight (kg) / height2 (m2). BMI ranging from 18 to 28 kg/m2 (including critical values);
- Physical examination and vital signs are normal or abnormal without clinical significance.
Who cannot join
- More than 5 cigarettes per day on average 3 months before the trial;
- Allergic constitution (allergic to multiple drugs and foods), or known to be possibly allergic to drugs of the same class of the IMP or highly sensitive to clopidogrel;
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or use of hard drug within the past five years;
- Blood donation or massive blood loss (>450 mL) within 3 months before screening;
- Presence of dysphagia or history of any gastrointestinal and hepatic, renal disease (whether cured or not) or history of surgery that affects absorption or excretion of the IMP within 6 months prior to screening;
- With any disease that increases the risk of bleeding, such as acute gastritis, stomach and duodenal ulcers, or history of abnormal bleeding (e.g. bleeding time prolonged after tooth extraction);
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- The subject or his or her immediate family member has a family history of coagulation or haemorrhagic disorders (such as haemophilia)/symptoms (such as hematemesis, melena, severe or recurrent epistaxis, coughing blood (hemoptysis), obvious hematuria or intracranial hemorrhage), or suspected vascular malformation, such as aneurysm or early-onset stroke;
- Took potent inhibitors and/or inducers of CYP enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5) within 28 days prior to the first dose. Potent inhibitors of CYP enzymes include ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc.. Potent inducers of CYP enzymes include rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc.. See Appendix 6 for details;
- Took any prescription, non-prescription, any vitamin or herbal drugs within 14 days before the first dose;
- Had foods that affect CYP3A4 metabolism within 2 weeks prior to the first dose, such as grapefruit or grapefruit-containing beverages, or had intense physical exercise (e.g. strength training, aerobic training, and playing football) within 7 days prior to the first dose, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- Recently there have been major changes in diet or exercise habits;
- Participated in a another clinical study within 3 months prior to screening (a subject may be enrolled if he/she withdraws from the study prior to treatment, i.e., the subject is not randomized or doesn't receive treatment);
- Failure to tolerate high-fat meals (two boiled eggs, one slice of toast with butter and bacon, a box of French fries, a glass of whole milk);
- 12-lead ECG abnormalities have clinical significance;
- Female subjects who are in lactation or positive for serum pregnancy test in the screening period or during the trial;
- Clinical laboratory abnormalities have clinical significance or other clinically significant diseases before screening (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, and lung, immune, mental or cardiovascular and cerebrovascular diseases);
- Positive for viral hepatitis (including hepatitis B and C), HIV antibody and treponema pallidum antibody during screening;
- Any acute diseases or concomitant medicines from screening period to before taking the IMPs;
- Took chocolate, any food or drink with caffeine or xanthine within 24 hours before the first dose;
- Took any alcoholic product or alcohol breath test is positive within 24 hours before the first dose;
- Urine drug screening positive;
- The investigator believes that there are other factors that are not suitable for participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study will adopt a randomized, open-label, single-dose, 3-cycle, 3-way crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules under fasted and fed conditions in health subjects.
- Conditions
- Acute Coronary Syndrome
- Being tested
- vicagrel
- 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.
vicagrelDrug
Oral administration after fasting/high-fat meal/low-fat meal
| Study group | Role | What they receive |
|---|---|---|
| KGD | Experimental | Oral administration after fasting/high-fat meal/low-fat meal Receives: Drug: vicagrel |
| GDK | Experimental | Oral administration after high-fat meal/low-fat meal/fasting Receives: Drug: vicagrel |
| DKG | Experimental | Oral administration after low-fat meal/fasting/high-fat meal Receives: Drug: vicagrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area Under the Curve From Time Zero to Last Quantifiable Concentration
Measured: 48 hours
Cmax
Peak concentration
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start24 Aug 2021
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
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 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
- Model description
- Single-center, randomized, open-label, single-dose, fasted/high-fat meal/low-fat meal, 3-cycle, 3-way crossover
- Masking
- None (open label)
- Enrolment
- 24 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, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919551
- Sponsor's protocol ID
- VCP1-Ⅰ-05
- Status last verified
- Oct 2021
- First submitted
- 8 Jun 2021
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04919551
- Acronym / sponsor ID
- VCP1-Ⅰ-05
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 9 Jun 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 a randomized, open-label, single-dose, 3-cycle, 3-way crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules under fasted and fed conditions in health subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single-center, randomized, open-label, single-dose, fasted/high-fat meal/low-fat meal, 3-cycle, 3-way crossover
| Arm | Type | Receives |
|---|---|---|
| KGD | Experimental | Drug: vicagrelOral administration after fasting/high-fat meal/low-fat meal |
| GDK | Experimental | Drug: vicagrelOral administration after high-fat meal/low-fat meal/fasting |
| DKG | Experimental | Drug: vicagrelOral administration after low-fat meal/fasting/high-fat meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntary signing of informed consent before the trial, and full understanding of the experimental content, process and possible ARs;
- Able to complete the study according to the protocol;
- Subjects (and their partners) are willing to take effective contraceptive measures from screening to 6 month after the last dose of the IMPs. See Appendix 5 for specific contraceptive measures;
- Male and female subjects aged 18 to 45 years (inclusive);
- Male weight ≥50 kg, female weight ≥ 45 kg. Body mass index (BMI) = body weight (kg) / height2 (m2). BMI ranging from 18 to 28 kg/m2 (including critical values);
Key exclusion criteria (22 listed)
- More than 5 cigarettes per day on average 3 months before the trial;
- Allergic constitution (allergic to multiple drugs and foods), or known to be possibly allergic to drugs of the same class of the IMP or highly sensitive to clopidogrel;
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or use of hard drug within the past five years;
- Blood donation or massive blood loss (>450 mL) within 3 months before screening;
- Presence of dysphagia or history of any gastrointestinal and hepatic, renal disease (whether cured or not) or history of surgery that affects absorption or excretion of the IMP within 6 months prior to 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 |
|---|---|---|
| vicagrelOral administration after fasting/high-fat meal/low-fat meal | Drug | DKG, GDK, KGD |
Primary outcome
AUC
Time frame: 48 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration
Cmax
Time frame: 48 hours
Peak concentration
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 1 Nov 2021.
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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
The First Hospital of Jilin 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 vicagrel in people with Acute Coronary Syndrome, 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 6 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 1 Nov 2021. 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?
AUC (time frame: 48 hours). The study lists 2 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 1 Nov 2021.