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Trial Title:
A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
NCT ID:
NCT06619951
Condition:
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Conditions: Official terms:
Itraconazole
Rifampin
Conditions: Keywords:
Healthy Volunteers
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VC004 and Itraconazole
Description:
A single dose of VC004 was administered in the period 1. and a single dose of VC004 and
Itraconazole coadministration in the period 2.
Arm group label:
Group 1: VC004 and itraconazole
Intervention type:
Drug
Intervention name:
VC004 and rifampicin
Description:
A single dose of VC004 was administered in the period 1. and a single dose of VC004 and
rifampicin coadministration in the period 2.
Arm group label:
Group 2: VC004 and rifampicin
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.
Criteria for 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;
- 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhongda Hospital,Affiliated to Southeast University
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Ling Liu, M.D.
Phone:
13913968688
Email:
wenyu811@126.com
Start date:
October 30, 2024
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Jiangsu vcare pharmaceutical technology co., LTD
Agency class:
Industry
Source:
Jiangsu vcare pharmaceutical technology co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06619951
