Obesity &Amp; OverweightPhase 1NCT07056842
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 Phase 1 study testing Rifampin + VCT220 and Itraconazole + VCT220 in people with Obesity &Amp; Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- Rifampin + VCT220 and Itraconazole + VCT220
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
- 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.
- Special dietary requirements incompatible with standardized study meals.
- Poor venous access or history of syncope during venipuncture or blood collection.
- 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.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
About this study
Official title: 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
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.
Read the detailed description
This is a single-center, open-label, single-arm, fixed-sequence Phase I clinical study designed to evaluate the effect of multiple doses of rifampin or itraconazole on the pharmacokinetics (PK) of VCT220 and its primary metabolite, VCT289, in healthy subjects. The study includes two cohorts.
Cohort 1 (Rifampin group):
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, participants will receive rifampin 600 mg followed 30 minutes after breakfast by VCT220 160 mg. All doses will be administered under fed or fasting conditions as specified, with restrictions on fluid intake and fasting periods post-dose to standardize absorption conditions.
Cohort 2 (Itraconazole group):
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, a single dose of VCT220 40 mg will be co-administered with itraconazole 200 mg after breakfast, under standardized fed conditions.
A total of 32 healthy adult subjects will be enrolled, with 16 subjects per cohort.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- Rifampin + VCT220, Itraconazole + VCT220
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifampin + VCT220Drug
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.
Itraconazole + VCT220Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Drug: Rifampin + VCT220; Drug: Itraconazole + VCT220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220.
Rifampin Cohort
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the 1st dosing day and 1-2 days after last treatment (day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start20 Jul 2025
- Primary completion11 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincentage Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056842
- Sponsor's protocol ID
- VCT220-I-04-02
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07056842
- Acronym / sponsor ID
- VCT220-I-04-02
- Conditions
- Obesity &Amp; Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vincentage Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, open-label, single-arm, fixed-sequence Phase I clinical study designed to evaluate the effect of multiple doses of rifampin or itraconazole on the pharmacokinetics (PK) of VCT220 and its primary metabolite, VCT289, in healthy subjects. The study includes two cohorts.
Cohort 1 (Rifampin group):
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, participants will receive rifampin 600 mg followed 30 minutes after breakfast by VCT220 160 mg. All doses will be administered under fed or fasting conditions as specified, with restrictions on fluid intake and fasting periods post-dose to standardize absorption conditions.
Cohort 2 (Itraconazole group):
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, a single dose of VCT220 40 mg will be co-administered with itraconazole 200 mg after breakfast, under standardized fed conditions.
A total of 32 healthy adult subjects will be enrolled, with 16 subjects per cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Rifampin + VCT220, Drug: Itraconazole + VCT220 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampin + VCT220Participants 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. | Drug | Experimental Arm |
| Itraconazole + VCT220Participants 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. | Drug | Experimental Arm |
Primary outcome
Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220.
Time frame: 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
Rifampin Cohort
Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220
Time frame: 1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
Itraconazole Cohort
Maximum observed plasma concentration (Cmax) for VCT220
Time frame: 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
Rifampin Cohort
Maximum observed plasma concentration (Cmax) for VCT220
Time frame: 1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
Itraconazole Cohort
1 secondary outcome
Number of participants with adverse events
Time frame: From the 1st dosing day and 1-2 days after last treatment (day 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rifampin + VCT220 and Itraconazole + VCT220 in people with Obesity &Amp; Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220. (time frame: 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.