ClinicalTrials.gg
CompletedNCT06619951Updated Dec 10, 2024

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

A Phase 1 interventional study of VC004 and Itraconazole and VC004 and rifampicin in Locally Advanced or Metastatic Solid Tumor, sponsored by Jiangsu vcare pharmaceutical technology co., LTD. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Jiangsu vcare pharmaceutical technology co., LTD · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Locally Advanced or Metastatic Solid Tumor

Browse trials for

Keywords

  • Healthy Volunteers
03

In context

Neoplasm Metastasis

3,562 studies on the registry are indexed under Neoplasm Metastasis; 875 are open to participants now.

This study's enrollment of 56 is close to the median of 54 across 2,800 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD is the lead sponsor of 35 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Group 1: VC004 and itraconazole

    Drug: VC004 and Itraconazole

  • Experimental
    Group 2: VC004 and rifampicin

    Drug: VC004 and rifampicin

Interventions

  • DrugVC004 and Itraconazole

    Drug pages: Eratrectinib · Itraconazole

    A single dose of VC004 was administered in the period 1. and a single dose of VC004 and Itraconazole coadministration in the period 2.

  • DrugVC004 and rifampicin

    Drug pages: Eratrectinib · Rifampin

    A single dose of VC004 was administered in the period 1. and a single dose of VC004 and rifampicin coadministration in the period 2.

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day1-Day16

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC)

    Time frame: Day1-Day16

07

Study locations

1 site
  • Zhongda Hospital,Affiliated to Southeast University
    Nanjing, Jiangsu, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06619951
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Sep 18, 2024
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Dec 10, 2024

Study contacts

Ling Liu, M.D.
principal investigator · Zhongda Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Eratrectinib · Itraconazole · Rifampin

Start the discussion