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

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic Solid Tumor
• Intervention / Treatment: Drug: VC004 and Itraconazole; Drug: VC004 and rifampicin

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Zhongda Hospital,Affiliated to Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: VC004 and itraconazole	Drug: 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.
Experimental: Group 2: VC004 and rifampicin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	Day1-Day16
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）		Day1-Day16

Collaborators and Investigators

• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
• Investigators: Principal Investigator: Ling Liu, M.D., Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents; Cytochrome P-450 CYP3A Inhibitors; Leprostatic Agents; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inducers; 14-alpha Demethylase Inhibitors; Rifampin; Itraconazole
• Other Study ID Numbers: VC004-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No