MedDataX Logo

A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects

NCT ID: NCT06619951

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-18

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will adopt a Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced or Metastatic Solid Tumor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: VC004 and itraconazole

Group Type EXPERIMENTAL

VC004 and Itraconazole

Intervention Type DRUG

A single dose of VC004 was administered in the period 1. and a single dose of VC004 and Itraconazole coadministration in the period 2.

Group 2: VC004 and rifampicin

Group Type EXPERIMENTAL

VC004 and rifampicin

Intervention Type DRUG

A single dose of VC004 was administered in the period 1. and a single dose of VC004 and rifampicin coadministration in the period 2.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VC004 and Itraconazole

A single dose of VC004 was administered in the period 1. and a single dose of VC004 and Itraconazole coadministration in the period 2.

Intervention Type DRUG

VC004 and rifampicin

A single dose of VC004 was administered in the period 1. and a single dose of VC004 and rifampicin coadministration in the period 2.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 6 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 between 19.0-26.0 kg/m2, inclusive;

Exclusion Criteria

* More than 5 cigarettes per day on average within 3 months prior to screening;
* with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiangsu vcare pharmaceutical technology co., LTD

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ling Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongda Hospital,Affiliated to Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VC004-106

Identifier Type: -

Identifier Source: org_study_id