A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult Subjects

NCT04919551 | Completed Phase 1 FDA Drug

• 1 other identifier: VCP1-Ⅰ-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• AUC

  Area Under the Curve From Time Zero to Last Quantifiable Concentration

  48 hours

• Cmax

  Peak concentration

  48 hours

Study Arms (3)

KGD

EXPERIMENTAL

Oral administration after fasting/high-fat meal/low-fat meal

Drug: vicagrel

GDK

EXPERIMENTAL

Oral administration after high-fat meal/low-fat meal/fasting

Drug: vicagrel

DKG

EXPERIMENTAL

Oral administration after low-fat meal/fasting/high-fat meal

Drug: vicagrel

Interventions

vicagrel DRUG

Oral administration after fasting/high-fat meal/low-fat meal

DKG; GDK; KGD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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);
• 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;

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

methyl 2-(2-acetoxy-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-2-(2-chlorophenyl)acetate

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yanhua Ding

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, open-label, single-dose, fasted/high-fat meal/low-fat meal, 3-cycle, 3-way crossover

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 9, 2021
• Study Start: August 24, 2021
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

CN (1)