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

Phase 1

Completed

• Conditions: Locally Advanced or Metastatic Solid Tumor
• Interventions: Drug: VC004 and Itraconazole; Drug: VC004 and rifampicin

• Registration Number: NCT06619951
• Lead Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-09-18
• Study First Submitted: 2024-09-28
• Study First Submitted QC: 2024-09-28
• Study First Posted: 2024-10-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1: VC004 and itraconazole	VC004 and Itraconazole	-
Group 2: VC004 and rifampicin	VC004 and rifampicin	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	Day1-Day16	Maximum Observed Plasma Concentration (Cmax)
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）	Day1-Day16

Trial Locations

Locations (1)

Zhongda Hospital,Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China