PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers

Recruiting at 2 trial locations

Overseen By Xiaojuan Lai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Must not be taking: CYP inhibitors, CYP inducers

Disqualifiers: Smoking, Drug abuse, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 31 days

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two blood-thinning medications, Vicagrel and Clopidogrel, in healthy people who process these drugs differently. The goal is to see how well these medications work in preventing blood clots. Vicagrel is a new medication developed to address the limitations of Clopidogrel.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any prescription drugs, over-the-counter drugs, vitamins, or herbal medicines at least 14 days before starting the study medication.

What safety data exists for vicagrel and clopidogrel in humans?

Vicagrel, a drug similar to clopidogrel, has been tested in healthy people and found to be safe and well-tolerated, even at higher doses. Although some side effects were noted, none were serious, suggesting it is generally safe for human use. ^{1 2 3 4 5}

How is this drug different from other treatments for its condition?

Vicagrel is a new drug similar to clopidogrel, but it may offer different effects on platelet activity, which is important for preventing blood clots. It is being studied for its unique properties compared to clopidogrel, especially in how it is processed in the body and its impact on platelet reactivity. ^{2 6 7 8 9}

What data supports the effectiveness of the drug Clopidogrel Tablets, Clopidogrel Tablets (PLAVIX), and vicagrel Capsules?

Clopidogrel, known as Plavix, is effective in preventing heart attacks and strokes by stopping blood clots from forming, as shown in several studies. It has been found to be more effective than aspirin for patients with certain heart conditions. ^{9 10 11 12 13}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

With normal or clinically insignificant abnormal results of physical examination and vital signs test;

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;

Exclusion Criteria

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;

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;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 7-day cross-dosing of vicagrel and clopidogrel between two cycles

31 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clopidogrel Tablets
• Clopidogrel Tablets（PLAVIX ）
• vicagrel Capsules

How Is the Trial Designed?

Group I: Ultra-rapid metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group II: Rapid metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group III: Poor metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group IV: Normal metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Group V: Intermediate metabolizers group Experimental Treatment 2 Interventions

A 7-day cross-dosing of vicagrel and clopidogrel between two cycles

Who Is Running the Clinical Trial?

Jiangsu vcare pharmaceutical technology co., LTD

Lead Sponsor

Trials

20

Recruited

3,000+

Published Research Related to This Trial

Clopidogrel is significantly more effective than aspirin for preventing atherothrombotic events in patients with established atherosclerotic disease, as shown in the CAPRIE study.

In patients with acute coronary syndromes, clopidogrel provides substantial benefits over placebo, but adding aspirin to clopidogrel does not improve outcomes in patients with cerebrovascular disease, according to the MATCH trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clopidogrel: cardiologists' panacea or neurologists' headache? Bezerra, DC., Bogousslavky, J.[2009]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Clopidogrel: cardiologists' panacea or neurologists' headache? [2009]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative pharmacokinetics/pharmacodynamics of clopidogrel besylate and clopidogrel bisulfate in healthy Korean subjects. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Monitoring of clopidogrel action: comparison of methods. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Clopidogrel. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Factors that contribute to clopidogrel resistance in cardiovascular disease patients: environmental and genetic approach. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Platelet inhibitory activity, tolerability, and safety of vicagrel, a novel thienopyridine P2Y12 inhibitor. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of vicagrel, a novel thienopyridine P2Y12 inhibitor, compared with clopidogrel in healthy Chinese subjects following single oral dosing. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Tolerability, Pharmacokinetics and Pharmacodynamics of Vicagrel, a Novel P2Y12 Antagonist, in Healthy Chinese Volunteers. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Species Comparison of Pre-systemic Bioactivation of Vicagrel, a New Acetate Derivative of Clopidogrel. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Development and validation of a sensitive and rapid UHPLC-MS/MS method for the simultaneous quantification of the common active and inactive metabolites of vicagrel and clopidogrel in human plasma. [2019]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative fasting bioavailability of two clopidogrel formulations in healthy Mediterranean volunteers: an in vitro-in vivo correlation. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Comparison of effects of two different formulations of clopidogrel bisulfate tablets on platelet aggregation and bleeding time in healthy Korean volunteers: A single-dose, randomized, open-label, 1-week, two-period, phase IV crossover study. [2018]

13. China pubmed.ncbi.nlm.nih.gov

[Effect of Clopidogrel on Pharmacokinetic of Fufang Danshen Dripping Pill (FDDP)]. [2022]