How a standard meal affects VV119 capsules in healthy adults
Official title: Study of Food Effects of VV119 Capsules in Chinese Healthy Volunteers
Run by Vigonvita Life Sciences · NCT07240636 · Data updated 2026-11-12
Researchers will test whether eating a standard meal changes how VV119 capsules are absorbed in healthy adult volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Vigonvita Life Sciences Industry-sponsored |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT07240636 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults who meet the trial's age, weight, and BMI criteria (males 18–45 years with ≥50 kg; females 18–60 years with ≥45 kg; BMI 19–26 kg/m2), are medically well, and can consent and comply with study procedures.
✕Probably not a fit
People with active medical conditions, pregnant women or those of child-bearing potential, and patients seeking therapeutic benefit would not be expected to receive clinical benefit from this pharmacokinetic study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, open-label 2×2 crossover phase 1 trial will give a single oral dose of VV119 to healthy adult volunteers under fed and fasting conditions to measure pharmacokinetics. Participants are randomized to dosing sequences with a washout between periods to compare standard meal versus fasting effects on absorption and systemic exposure. Safety monitoring includes physical exams, vital signs, laboratory tests, and ECGs with adverse event reporting. The trial is conducted at The First Affiliated Hospital of Anhui Medical University in Hefei, China.
Why it matters
Potential benefit: If successful, the results could show whether VV119 should be taken with or without food, informing dosing instructions to improve safety and effectiveness in later studies.
How similar studies have gone: Food-effect crossover pharmacokinetic studies are a standard and successful approach for determining meal impacts on oral drug absorption, although VV119 itself has not previously been characterized this way.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2, 2. Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance, 3. Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential, 4. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form. Exclusion Criteria: 1. With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial; 2. With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation; 3. With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc. 4. With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution; 5. Positive for hepatitis B virus surface antigen (HBsAg), or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen/antibody combined detection (HIV-Ag/Ab); 6. With a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial; 7. With a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a blood donation or blood loss ≥ 200 mL within 1 month, or a history of blood product use within 3 months before screening; 8. Taking any prescription drugs, over-the-counter drugs, and any functional vitamins or herbal products within 2 weeks before screening; 9. Using any drugs that inhibit or induce hepatic drug metabolizing enzymes CYP3A4, CYP3A5, CYP2D6 (such as inducers - phenobarbital, rifampicin, carbamazepine, phenytoin sodium, glucocorticoids, etc.; inhibitors - ketoconazole, itraconazole, cimetidine, clarithromycin, verapamil, erythromycin, etc.) within 4 weeks (or 5 half-lives, whichever is longer) before screening; 10. Participating in any clinical trial and taking clinical trial drugs within 3 months before screening, or being participating in other clinical trials; 11. Smoke test positive or smoking more than 5 cigarettes per day or average intake of coffee or tea more than 5 cups per day (200 mL/cup) within 3 months before screening, or unable to stop users during the study; 12. With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units \[1 unit = 360 mL beer (alcohol content 5%) or 45 mL spirits (alcohol content 40%) or 150 mL wine (alcohol content 12%)\] or positive for alcohol breath test; 13. With a history of drug abuse within 1 year before screening, or positive for urine drug screening; 14. With a family history of sudden cardiac death (sudden death age less than 40 years); 15. With a resting pulse \< 50 beats/min or ≥ 100 beats/min; resting systolic blood pressure \< 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure \< 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg and/or diastolic blood pressure decreased by ≥ 10 mmHg and/or accompanied by clinical symptoms within 3 minutes of standing; 16. Abnormal in 12-lead electrocardiogram (ECG), clinically significant judged by the investigator (e.g., QTcF\> 450 ms in men and \> 470 ms in women); 17. With the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (Cr), urea (Urea), serum prolactin levels beyond the upper limit of normal (ULN); 18. Having special requirements for food, unable to observe a unified diet or having dysphagia; 19. Rejecting abide by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided; 20. Directly related to this clinical trial; 21. Other subjects that the investigator considers inappropriate for this trial.
Where it's running
-
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting
Study contacts
- Principal investigator: Huan Zhou — The First Affiliated Hospital of Anhui Medical University
- Study coordinator: Huaqing Duan
- Email: huaqing.duan@vigonvita.cn
- Phone: +8618061926005
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.