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

NCT07065058 | Completed Phase 1 FDA Drug

• 1 other identifier: VCT220-I-04-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity &Amp; Overweight

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Repaglinide

  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

  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

  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

  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

  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

  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

Secondary Outcomes (1)

• Safety of VCT220

  From day 0 to day 78

Study Arms (1)

Participant Group

EXPERIMENTAL

During the monotherapy phase, subjects receive repaglinide, rosuvastatin, and digoxin. After a 1-week washout period, VCT220 is administered starting from 20 mg and titrated up to 160 mg, followed by repeat administration of repaglinide, rosuvastatin, and digoxin.

Drug: Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin

Interventions

Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin DRUG

Single dose of Repaglinide at Day 2, Rosuvastatin and Digoxin at Day 3 Orally VCT220 once daily from Day 9 to Day 78, titrated from 20mg to 160mg. Co-administrated Repaglinide at Day 72, co-administrated Rosuvastatin and Digoxin at Day 73

Participant Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any of the following laboratory abnormalities at screening:
• HbA1c ≥ 6.5%;
• Fasting plasma glucose (FPG) ≥ 7.0 mmol/L;
• Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m² (calculated by CKD-EPI formula);
• ALT and/or AST \> 1.5× upper limit of normal (ULN);
• Total bilirubin (TBIL) \> 1.5× ULN;
• Serum amylase or lipase \> 1.5× ULN;
• Calcitonin ≥ 1.0× ULN;
• Hemoglobin \< 110 g/L (males) or \< 100 g/L (females).
• Positive test results for any of the following: HBsAg, HCV-Ab, HIV-Ab, or TP-Trust (syphilis).
• lead ECG during screening showing second- or third-degree atrioventricular block, long QT syndrome, QTcF ≥ 450 ms (males) or ≥ 470 ms (females) (QTcF = QT/RR\^0.33), bundle branch block, Wolff-Parkinson-White syndrome, or other clinically significant arrhythmias (excluding sinus arrhythmia), or ECG findings deemed clinically significant by the investigator.
• Known allergy to VCT220, repaglinide, rosuvastatin, or digoxin, or history of allergy to two or more drugs or foods.
• History or current diagnosis of pancreatitis (acute or chronic), history of acute gallbladder disease (except for those who have undergone cholecystectomy), or clinically significant findings on baseline abdominal ultrasound.
• Diagnosis of type 1, type 2, or other specific types of diabetes.
• Use of GLP-1 receptor agonists within 6 months before screening.

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

repaglinide; Rosuvastatin Calcium; Digoxin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

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

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 15, 2025
• Study Start: July 1, 2025
• Primary Completion: July 11, 2025
• Study Completion: August 11, 2025
• Last Updated: March 31, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)