Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects

Jiangsu vcare pharmaceutical technology co., LTD1 site in 1 country84 target enrollmentJuly 22, 2024

ConditionsLocally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

InterventionsHigh Dose VC004 Capsules Median Dose VC004 Capsules Low Dose VC004 Capsules

DrugsHigh Dose VC004 Capsules Median Dose VC004 Capsules Low Dose VC004 Capsules

Overview

Phase: Phase 1
Intervention: High Dose VC004 Capsules
Conditions: Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Enrollment: 84
Locations: 1
Primary Endpoint: Peak time(Tmax)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect and Relative bioavailability of VC004 Capsules in healthy subjects

Registry

clinicaltrials.gov

Start Date

July 22, 2024

End Date

August 26, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Responsible Party

Sponsor

Eligibility Criteria

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 (see Appendix 5 for details);
•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 (BMI= Weight/Height2) 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 medication, food, mites, etc., or those known to be potentially allergic to drugs of the same class as the study drug;
•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;
•History of difficulties in swallowing or any history of gastrointestinal(such as reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion within 6 months prior to screening;
•Those who Have taken strong inhibitors and / or inducers of liver metabolic enzymes (CYP1A2, 2A6, 2b6, 2c8, 2c19, 3A4 and 3A5) within 28 days prior to screening :strong inhibitors of liver metabolic enzymes such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, oleandomycin etc., strong inducers of liver metabolic enzymes such as rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc; Those who Have taken inhibitors and inducers of P-gp, MRPs, BCRP, OATP and other transporters and transporters within 28 days prior to screening; See Appendix 5 for details;
•Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to screening;
•Taking foods that affect CYP3A4 metabolism, such as grapefruit or drinks containing grapefruit within 2 weeks prior to screening, or taking high-intensity physical exercises (such as strength training, aerobic training and football playing) within 7 days prior to screening, or any other factors that affect drug absorption, distribution, metabolism and excretion;
•Participated in other clinical trials within 3 months before screening (if the subject withdraws from the study before treatment, i.e. has not been randomized or received treatment, he or she can be enrolled in the study);
•Those who cannot tolerate high-fat meals or have special requirements for diet and cannot accept unified diet；