NCT07796191

Brief Summary

This study includes three groups of Drug-Drug Interaction( DDI ) studies:

  1. 1.To evaluate the effect of verapamil on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
  2. 2.To evaluate the effect of probenecid on the pharmacokinetics of a single oral dose of VC005 in healthy subjects;
  3. 3.To evaluate the effect of VC005 on the pharmacokinetics of a single oral dose of metformin tablets in healthy subjects.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Sep 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 27, 2026

Last Update Submit

August 27, 2026

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax)

    Day1-Day12

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）

    Day1-Day12

Study Arms (3)

VC005 and verapamil

EXPERIMENTAL
Drug: VC005 and verapamil

VC005 and probenecid

EXPERIMENTAL
Drug: VC005 and probenecid

VC005 and metformin

EXPERIMENTAL
Drug: VC005 and metformin

Interventions

VC005 and verapamilDRUG

A single dose of VC005 was administered in the period 1. and a single dose of VC005 and verapamil coadministration in the period 2.

VC005 and verapamil
VC005 and probenecidDRUG

A single dose of VC005 was administered in the period 1. and a single dose of VC005 and probenecid coadministration in the period 2.

VC005 and probenecid
VC005 and metforminDRUG

A single dose of metformin was administered in the period 1. and a single dose of metformin and VC005 coadministration in the period 2

VC005 and metformin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions;
  • Able to complete the study in compliance with the protocol;
  • Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 3 months after the last dose of study drug ；
  • Male and female subjects between the ages of 18 and 45 years, inclusive;
  • At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index (BMI= Weight/Height2) between 19.0-26.0 kg/m2, inclusive;

You may not qualify if:

  • More than 5 cigarettes per day on average within 3 months prior to screening;
  • Subjects with a history of allergy, including allergy to drugs, food, dust mites, etc., or known hypersensitivity to drugs of the same class as the investigational product, or known hypersensitivity to verapamil, probenecid, metformin, or any of the excipients;
  • History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years;
  • Donation or loss of a significant volume of blood (\> 400 mL) within 3 months prior to screening;
  • History of difficulties in swallowing or any history of gastrointestinal, liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion；
  • Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital,Affiliated to Southeast University

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

VerapamilProbenecidMetformin

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsSulfonamidesAmidesSulfonesSulfur CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • linlin Hu

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations

CN(1)