This is an Open-label, Non-randomized Study to Assess the Pharmacokinetics (PK) of VCT220 in Heal… (NCT07056842) | Clinical Trial Compass
CompletedPhase 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
China32 participantsStarted 2025-07-20
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220.
Timeframe: 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
2
Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220
Timeframe: 1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
3
Maximum observed plasma concentration (Cmax) for VCT220
Timeframe: 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
4
Maximum observed plasma concentration (Cmax) for VCT220
Timeframe: 1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose
. 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.