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

Jiangsu Vcare PharmaTech

Status and phase

Completed

Phase 1

Conditions

Locally Advanced or Metastatic Solid Tumor

Treatments

Drug: VC004 and Itraconazole

Drug: VC004 and rifampicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06619951

VC004-106

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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;