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 range18 Years – 65 Years

SexALL

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

✕. Any of the following laboratory abnormalities at screening:
✕. HbA1c ≥ 6.5%;
✕. Fasting plasma glucose (FPG) ≥ 7.0 mmol/L;

What they're measuring

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

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

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

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

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

Maximum Observed Concentration (Cmax) 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

Trial details

NCT IDNCT07065058

SponsorVincentage Pharma Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-11

View on ClinicalTrials.gov More Obesity &Amp; Overweight trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

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

✕. Any of the following laboratory abnormalities at screening:
✕. HbA1c ≥ 6.5%;
✕. Fasting plasma glucose (FPG) ≥ 7.0 mmol/L;

What they're measuring

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

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

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

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

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

Maximum Observed Concentration (Cmax) 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