This is an Open-label, Non-randomized Study to Assess the Pharmacokinetics (PK) of VCT220 in Healthy Volunteers When Administered With Rifampin or Itraconazole

Launched by VINCENTAGE PHARMA CO., LTD · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a new medicine called VCT220 behaves in the body when taken along with two other medicines, rifampin or itraconazole. These two medicines can affect how drugs work in the body, so researchers want to understand if they change how VCT220 is absorbed, processed, or eliminated. The study will be done in healthy adults to see how VCT220 and its related compound, VCT289, act when given with these medicines.

Adults between 18 and 50 years old who are generally healthy, with a body weight and body mass index (BMI) in a certain range, may be eligible to join. Participants will need to communicate well, understand the study, and agree to follow the rules, including using birth control if applicable. This study will involve taking single doses of VCT220 along with daily doses of rifampin or itraconazole, and participants will be closely monitored through tests and check-ups. The study is not yet recruiting, and people with certain health conditions or who take specific medications will not qualify. If you join, you can expect careful supervision to ensure your safety while researchers learn more about how these medicines interact.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants are able to communicate well with the investigators, fully understand the purpose, content, procedures, and potential adverse events of the study, comprehend and comply with all study requirements, and voluntarily sign the informed consent form (ICF).
• • 2. Healthy male and female participants aged between 18 and 50 years (inclusive).
• • 3. Male participants must weigh ≥50.0 kg, and female participants must weigh ≥45.0 kg. Body Mass Index (BMI) must be within the range of 19.0 to 28.0 kg/m² (inclusive), calculated as weight (kg)/height² (m²).
• • 4. Participants must have no plans for conception and must voluntarily use effective contraception from the time of signing the ICF until 3 months after the last dose of study medication. No plans for sperm or egg donation during this period.
• Exclusion Criteria:
• • 1. Any clinically significant abnormalities as determined by the investigator in physical examination, vital signs, laboratory tests, abdominal ultrasound, or chest X-ray (frontal and lateral views) during screening.
• • 2. Positive test results for HBsAg, HCV-Ab, HIV-Ab, or TPPA.
• • 3. QTcF ≥450 ms for males or ≥470 ms for females on 12-lead ECG at screening (QTcF calculated using Fridericia's formula: QTcF = QT / RR\^0.33), or clinically significant ECG abnormalities as assessed by the investigator.
• • 4. Known allergy to VCT220, rifampin, or itraconazole, or history of hypersensitivity to two or more drugs or foods.
• • 5. History or presence of significant diseases of the nervous, cardiovascular (unless deemed acceptable by the investigator), hematologic, lymphatic, immune, digestive, urinary, respiratory, metabolic, or musculoskeletal systems.
• • 6. History or presence of pancreatitis (chronic or acute) or acute gallbladder disease (except those post-cholecystectomy).
• • 7. Prior diagnosis of type 1, type 2, or other specific types of diabetes.
• • 8. Use of GLP-1 receptor agonists within 6 months prior to screening.
• • 9. Difficulty swallowing or any gastrointestinal disease affecting drug absorption (e.g., diarrhea, vomiting, inflammatory bowel disease, acute gastroenteritis, peptic ulcer, or chronic GI dysfunction with marked malabsorption).
• • 10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• • 11. History of significant active or unstable major depression or other major psychiatric disorders within 2 years prior to screening.
• • 12. Underwent surgery within 3 months prior to screening, plans to undergo surgery during the study period, or had surgery affecting absorption, distribution, metabolism, or excretion of drugs.
• • 13. Participation in another drug/device clinical trial within 3 months prior to screening or planned participation during the study period.
• • 14. Blood donation (including components) or significant blood loss ≥400 mL, receipt of blood transfusion or blood products within 3 months prior to screening.
• • 15. Use of any prescription drugs (especially CYP3A4, CYP2C8, CYP2C9, and CYP2C19 inducers/inhibitors), over-the-counter medications, dietary supplements, or traditional Chinese medicine within 14 days prior to first dosing, or planning to use such substances during the study (excluding study medication).
• • 16. Vaccination within 14 days prior to screening or planned vaccination during the study.
• • 17. History of drug abuse or use of illicit drugs within 1 year prior to screening, or positive urine drug screening.
• • 18. Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain from tobacco during the study.
• • 19. Alcohol consumption \>14 units/week within 3 months prior to screening (1 unit ≈ 360 mL beer at 5% alcohol, 45 mL spirits at 40%, or 150 mL wine at 12%), or inability to abstain from alcohol, or positive alcohol breath test (\>0 mg/100 mL).
• • 20. Excessive consumption of tea, coffee, or caffeinated beverages (\>8 cups/day, 1 cup = 250 mL) within 3 months prior to screening, ingestion of caffeine-containing products within 24 hours before dosing, or unwillingness to abstain from caffeine during the study.
• • 21. Consumption of fruits or products that may affect drug metabolism (e.g., pitaya, mango, grapefruit, pomelo, oranges) within 2 days prior to first dosing, or unwillingness to abstain from these during the study.
• • 22. Special dietary requirements incompatible with standardized study meals.
• • 23. Poor venous access or history of syncope during venipuncture or blood collection.
• • 24. Pregnant or breastfeeding females; positive pregnancy test; or history of unprotected sex within 30 days prior to screening.
• • 25. Use of oral contraceptives within 30 days prior to first dosing.
• • 26. Use of long-acting estrogen or progestin injections (including progestin-releasing IUDs) or implants within 6 months prior to first dosing.
• • 27. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.