Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-04-07 @ 11:08 AM
Study NCT ID:
NCT07065058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Vincentage Pharma Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I, Single-Center, Open-Label, Single-Arm, Fixed-Sequence Clinical Study to Evaluate the Pharmacokinetic Interactions of VCT220 With Repaglinide, Rosuvastatin, and Digoxin in Healthy, Overweight, and Obese Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This is a single-center, open-label, single-arm, fixed-sequence Phase I clinical study designed to evaluate the effect of orally administered VCT220 tablets on the pharmacokinetics (PK) and safety of repaglinide, rosuvastatin, and digoxin in healthy, overweight, and obese adult subjects. These three drugs are probe substrates for key drug transporters: repaglinide for OATP1B1/OATP1B3, rosuvastatin for BCRP, and digoxin for P-glycoprotein (P-gp).
A total of 24 subjects will be enrolled. On Day 1, subjects receive a single dose of repaglinide 0.5 mg under fasting conditions. On Day 2, rosuvastatin 10 mg and digoxin 0.25 mg are co-administered under fed conditions. From Day 9 to Day 78, subjects will receive VCT220 orally once daily after breakfast in an ascending dose regimen: 20 mg, 40 mg, 80 mg, 120 mg, and finally 160 mg, titrated every 2 weeks.
On Day 72, repaglinide is administered again under fasting conditions, now in the presence of steady-state VCT220. On Day 73, rosuvastatin and digoxin are administered again under fed conditions with VCT220. Water intake is restricted within 1 hour before and after dosing, and standardized meals are provided to control for food effects.
Serial blood samples will be collected before and after dosing for PK assessments. The primary endpoints are the PK parameters (Cmax, AUC) of the probe drugs with and without VCT220. Safety will be evaluated throughout the study via clinical assessments, laboratory tests, vital signs, ECGs, and adverse event monitoring
A total of 24 subjects will be enrolled. On Day 1, subjects receive a single dose of repaglinide 0.5 mg under fasting conditions. On Day 2, rosuvastatin 10 mg and digoxin 0.25 mg are co-administered under fed conditions. From Day 9 to Day 78, subjects will receive VCT220 orally once daily after breakfast in an ascending dose regimen: 20 mg, 40 mg, 80 mg, 120 mg, and finally 160 mg, titrated every 2 weeks.
On Day 72, repaglinide is administered again under fasting conditions, now in the presence of steady-state VCT220. On Day 73, rosuvastatin and digoxin are administered again under fed conditions with VCT220. Water intake is restricted within 1 hour before and after dosing, and standardized meals are provided to control for food effects.
Serial blood samples will be collected before and after dosing for PK assessments. The primary endpoints are the PK parameters (Cmax, AUC) of the probe drugs with and without VCT220. Safety will be evaluated throughout the study via clinical assessments, laboratory tests, vital signs, ECGs, and adverse event monitoring
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: