Healthy SubjectsPhase 1NCT05651074
Assessment of the Effect of Omeprazole on Vicagrel in Healthy Subjects
A Phase 1 study testing Vicagrel and omeprazole in people with Healthy Subjects, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the effects of omeprazole on the PK and PD of a single dose of vicagrel 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
- What is being tested?
- Vicagrel and omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2022to Apr 2023
- 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
- 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 6 months after the last dose of study drug (see Appendix 5 for details);
- Male and female subjects between the ages of 18 and 45 years, inclusive;
- At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 18-28 kg/m2, inclusive;
- With normal or clinically insignificant abnormal results of physical examination and vital signs test;
- CYP2C19 normal metabolizers (CYP2C19*1/*1).
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, or hypersensitivity to omeprazole, other benzimidazoles, or any excipients, 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 unit = 285 mL beer, 25 mL spirit or 100 mL wines);
- Donation or loss of a significant volume of blood (> 450 mL) within 3 months 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 3 months 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Phase I Clinical Research Center of The First Hospital of Jilin University
Changchun, Jilin
Zhang Hong
About this study
Official title: A Pharmacokinetic/Pharmacodynamic Study to Evaluate the Effect of Omeprazole of Vicagrel in Healthy Subjects
The primary objective of the study is to evaluate the effects of omeprazole on the PK and PD of a single dose of vicagrel in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Vicagrel and omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicagrel and omeprazoleDrug
18 mg vicagrel capsules and 40 mg omeprazole magnesium enteric-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Vicagrel and omeprazole | Experimental | D1 single dose of vicagrel was administered. Omeprazole administration was started on D4, once daily for 5 days, and a single dose of vicagrel and omeprazole coadministration on day 9. Receives: Drug: Vicagrel and omeprazole |
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 vicagrel
Measured: Day 2 of each period
Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with vicagrel
Measured: Day 2 of each period
maximum plasma concentration (Cmax)
Measured: Up to 48 hours postdose on Day 3 for each period
Area under the concentration-time curve (AUC)
Measured: Up to 48 hours postdose on Day 3 for each period
Secondary outcomes (1)
Assess the safety of a single dose of vicagrel and a combination of vicagrel and omeprazole in healthy subjects by assessment of adverse events and symptoms and physical examination, clinical laboratory tests, vital signs,12-ECG.
Measured: Day1-Day11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start14 Nov 2022
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT05651074
- Sponsor's protocol ID
- VCP1-Ⅰ-07
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic/Pharmacodynamic Study to Evaluate the Effect of Omeprazole of Vicagrel in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05651074
- Acronym / sponsor ID
- VCP1-Ⅰ-07
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 14 Dec 2022 (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.
The primary objective of the study is to evaluate the effects of omeprazole on the PK and PD of a single dose of vicagrel in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vicagrel and omeprazole | Experimental | Drug: Vicagrel and omeprazoleD1 single dose of vicagrel was administered. Omeprazole administration was started on D4, once daily for 5 days, and a single dose of vicagrel and omeprazole coadministration on day 9. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 6 months after the last dose of study drug (see Appendix 5 for details);
- Male and female subjects between the ages of 18 and 45 years, inclusive;
- At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 18-28 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, or hypersensitivity to omeprazole, other benzimidazoles, or any excipients, 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 unit = 285 mL beer, 25 mL spirit or 100 mL wines);
- Donation or loss of a significant volume of blood (> 450 mL) within 3 months 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 and omeprazole18 mg vicagrel capsules and 40 mg omeprazole magnesium enteric-coated tablets | Drug | Vicagrel and omeprazole |
Primary outcome
Inhibition of platelet aggregation [IPA] evaluated in healthy subjects to treatment with vicagrel
Time frame: Day 2 of each period
Platelet reactivity index [PRI] evaluated in healthy subjects to treatment with vicagrel
Time frame: Day 2 of each period
maximum plasma concentration (Cmax)
Time frame: Up to 48 hours postdose on Day 3 for each period
Area under the concentration-time curve (AUC)
Time frame: Up to 48 hours postdose on Day 3 for each period
1 secondary outcome
Assess the safety of a single dose of vicagrel and a combination of vicagrel and omeprazole in healthy subjects by assessment of adverse events and symptoms and physical examination, clinical laboratory tests, vital signs,12-ECG.
Time frame: Day1-Day11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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.
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 and omeprazole in people with Healthy Subjects, 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 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Fei, 130021 (0431-88786014, wangfei5780@126.com), or a site near the patient. 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 vicagrel (time frame: Day 2 of each period). 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 31 Jan 2023.