A Drug Drug Interaction Study to Evaluate the Effect of VCT220 on the Pharmacokinetics of Repagli… (NCT07065058) | Clinical Trial Compass
CompletedPhase 1
A Drug Drug Interaction Study to Evaluate the Effect of VCT220 on the Pharmacokinetics of Repaglinide, Rosuvastatin, and Digoxin in Healthy, Overweight, and Obese Subjects
China24 participantsStarted 2025-07-01
Plain-language summary
This is a single-center, open-label, single-arm, fixed-sequence Phase I study in healthy, overweight, and obese subjects. The primary objective is to evaluate the effect of orally administered VCT220 tablets on the pharmacokinetics and safety of repaglinide , rosuvastatin, and digoxin.
A total of 24 subjects will be enrolled. Repaglinide is administered alone on Day 1 and coadministered with VCT220 on Day 72. Rosuvastatin and digoxin are administered together on Day 2 and again on Day 73 with VCT220. VCT220 will be titrated from 20 mg to 160 mg once daily from Day 9 to Day 78.
All study drugs are given under controlled fed or fasting conditions, with standardized water and meal restrictions. Intensive PK sampling will be conducted around dosing to assess any drug-drug interactions. Safety assessments will be conducted throughout the study.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must be fully informed of the purpose, content, procedures, and potential adverse reactions of the study, voluntarily agree to participate, and sign the informed consent form (ICF) prior to any study-related procedures.
. Male and female subjects aged between 18 and 65 years (inclusive).
. Male subjects must weigh ≥50.0 kg and female subjects ≥45.0 kg, with a body mass index (BMI) ≥20 kg/m² \[BMI = weight (kg) / height² (m²)\].
. Subjects must have no plans for childbearing from the time of signing the ICF until 3 months after the last dose of the study drug and must voluntarily agree to use effective contraception; subjects must also have no plans to donate sperm or eggs during this period.
. Subjects must be able to communicate well with the investigators, and understand and comply with all study requirements.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Repaglinide
Timeframe: 1h before dosing, 0.25 h、0.5 h、1 h、1.5 h、2 h、3 h、4 h、6 h、8 h、12 h and 24 h post dosing
2
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Rosuvastatin
Timeframe: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing
3
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Digoxin
Timeframe: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing
4
Maximum Observed Concentration (Cmax) of Repaglinide
Timeframe: 1h before dosing, 0.25 h、0.5 h、1 h、1.5 h、2 h、3 h、4 h、6 h、8 h、12 h and 24 h post dosing
5
Maximum Observed Concentration of Rosuvastatin
Timeframe: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing