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

NCT07056842 | Completed Phase 1 FDA Drug

• 1 other identifier: VCT220-I-04-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity &Amp; Overweight

Outcome Measures

Primary Outcomes (4)

• Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220.

  Rifampin Cohort

  1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose

• Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220

  Itraconazole Cohort

  1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose

• Maximum observed plasma concentration (Cmax) for VCT220

  Rifampin Cohort

  1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose

• Maximum observed plasma concentration (Cmax) for VCT220

  Itraconazole Cohort

  1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose

Secondary Outcomes (1)

• Number of participants with adverse events

  From the 1st dosing day and 1-2 days after last treatment (day 15)

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Drug: Rifampin + VCT220; Drug: Itraconazole + VCT220

Interventions

Rifampin + VCT220 DRUG

Participants will receive a single oral dose of VCT220 160 mg on Day 1. Rifampin 600 mg will be administered once daily from Day 4 to Day 10 and from Day 12 to Day 14. On Day 11, rifampin 600 mg will be administered followed 30 minutes later by VCT220 160 mg. All doses are administered under fed or fasting conditions with standardized restrictions on fluid and food intake.

Experimental Arm

Itraconazole + VCT220 DRUG

Participants will receive a single oral dose of VCT220 40 mg on Day 1. Itraconazole 200 mg will be administered once daily from Day 4 to Day 11 and from Day 13 to Day 14. On Day 12, VCT220 40 mg will be co-administered with itraconazole 200 mg after breakfast. All doses are administered under fed conditions with standardized fluid and fasting controls.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Positive test results for HBsAg, HCV-Ab, HIV-Ab, or TPPA.
• 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.
• 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).
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Rifampin; Itraconazole

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Design

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

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: July 20, 2025
• Primary Completion: August 11, 2025
• Study Completion: September 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)