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

NCT06619951 | Completed Phase 1

• 1 other identifier: VC004-106
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced or Metastatic Solid Tumor

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1: VC004 and itraconazole

EXPERIMENTAL

Drug: VC004 and Itraconazole

Group 2: VC004 and rifampicin

EXPERIMENTAL

Drug: VC004 and rifampicin

Interventions

VC004 and Itraconazole 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 1: VC004 and itraconazole

VC004 and rifampicin 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.

Group 2: VC004 and rifampicin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

Zhongda Hospital,Affiliated to Southeast University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Itraconazole; Rifampin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ling Liu, M.D.

  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: September 28, 2024
• First Posted: October 1, 2024
• Study Start: September 18, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-08

Locations

CN (1)