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NCT07056842CompletedPhase 1

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

A Single-Center, Open-Label, Single-Arm, Fixed-Sequence Phase I Clinical Study to Evaluate the Effect of Multiple Doses of Rifampin or Itraconazole on the Pharmacokinetics of VCT220 in Healthy Subjects

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

This is a single-center, open-label, single-arm, fixed-sequence Phase I study in healthy participants to evaluate the effect of multiple doses of rifampin or itraconazole on the pharmacokinetics (PK) of VCT220 and its metabolite VCT289. Cohort 1 will assess the impact of rifampin (600 mg once daily) on VCT220 (160 mg single dose). Cohort 2 will assess the impact of itraconazole (200 mg once daily) on VCT220 (40 mg single dose). A total of 32 healthy subjects will be enrolled, 16 in each cohort.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
32 (actual)
First submitted
29 Jun 2025
Start date
20 Jul 2025
Primary completion date
11 Aug 2025
Lead sponsor
Vincentage Pharma Co., Ltd
Diseases
Obesity
NCT number
NCT07056842

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 32
  • From 20 Jul 2025 to the primary completion date, 11 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior diagnosis of type 1, type 2, or other specific types of diabetes.
  • Use of GLP-1 receptor agonists within 6 months prior to screening.
  • History of significant active or unstable major depression or other major psychiatric disorders within 2 years prior to screening.
  • 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.
  • Participation in another drug/device clinical trial within 3 months prior to screening or planned participation during the study period.
  • Blood donation (including components) or significant blood loss ≥400 mL, receipt of blood transfusion or blood products within 3 months prior to screening.
  • 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).
  • Vaccination within 14 days prior to screening or planned vaccination during the study.
  • History of drug abuse or use of illicit drugs within 1 year prior to screening, or positive urine drug screening.
  • Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain from tobacco during the study.
  • 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).
  • 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.
  • 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.
  • Pregnant or breastfeeding females; positive pregnancy test; or history of unprotected sex within 30 days prior to screening.
  • Use of oral contraceptives within 30 days prior to first dosing.
  • Use of long-acting estrogen or progestin injections (including progestin-releasing IUDs) or implants within 6 months prior to first dosing.

Other illness

  • Positive test results for HBsAg, HCV-Ab, HIV-Ab, or TPPA.
  • Known allergy to VCT220, rifampin, or itraconazole, or history of hypersensitivity to two or more drugs or foods.
  • 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.
  • History or presence of pancreatitis (chronic or acute) or acute gallbladder disease (except those post-cholecystectomy).
  • 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).
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
  • Poor venous access or history of syncope during venipuncture or blood collection.
  • Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.

Lab values

  • 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.
  • 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.

Other

  • Special dietary requirements incompatible with standardized study meals.

Who the study is looking for

  • 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).
  • Healthy male and female participants aged between 18 and 50 years (inclusive).
  • 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).
  • 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.

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Shandong First Medical University
Coordinator of this site? Confirm its status
JinanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.