Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionPhase 1NCT05528120
Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
A Phase 1 study testing VC004 Capsules in people with Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed conditions in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
- What is being tested?
- VC004 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to 23 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- More than 5 cigarettes per day on average within 3 months prior to screening;
- History of sensitivity to drugs similar to the study drug;allergic constitution (e.g. allergy to two or more kinds of drugs and food );
- 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 (> 450 mL) within 3 months prior to screening;
- History of difficulties in swallowing or any history of gastrointestinal, 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 before the first administration :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 before the first administration; See Appendix 6 for details;
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- Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to receiving study drug;
- Taking foods that affect CYP3A4 metabolism, such as grapefruit or drinks containing grapefruit within 2 weeks before the first drug administration, or taking high-intensity physical exercises (such as strength training, aerobic training and football playing) within 7 days before the first drug administration, or any other factors that affect drug absorption, distribution, metabolism and excretion;
- Recent major changes in diet or exercise habits within 7 days before the first medication;
- 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；
- A clinically significant vital signs abnormality during screening (body temperature (axillary temperature) < 36.0 ℃ or > 37.0 ℃; Pulse < 60bpm or > 100bpm; Systolic blood pressure <90mmhg or ≥ 140mmHg, diastolic blood pressure <60mmhg or ≥ 90mmHg);
- A clinically significant 12-lead ECG abnormality;
- Positive test results of blood pregnancy or is lactating for female subjects;
- Any clinically significant abnormalities/findings in laboratory tests, or any clinically significant disease including but not limited to gastrointestinal, renal, hepatic, neurological system, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases;
- Positive test results for viral hepatitis (including hepatitis B and C), HIV antibody or syphilis antibody during screening;
- Acute illness or concomitant medication from screening to the first dosing of study medication;
- Consumption of chocolate or any food or beverages containing caffeine or (rich containing) xanthine within 24 h prior to receiving the first dosing of study medication;
- Consumption of any product containing alcohol within 24 h prior to receiving the first dosing of study medication, or positive results from a screen for alcohol;
- Positive results from a screen for urine drug test;
- Cannot tolerate venipuncture and have a history of needle and blood sickness;
- Subjects were vaccinated within 4 weeks prior to screening, or planned to be vaccinated during the trial;
- Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study or who are not suitable to participate according to the epidemic prevention and control requirements of the research center.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital,Affiliated to Southeast University
Nanjing, Jiangsu, 210009
About this study
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed conditions in healthy subjects.
- Being tested
- VC004 Capsules
- Keywords
- healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC004 CapsulesDrug
Oral administration after fasting/high-fat meal
VC004 CapsulesDrug
Oral administration after high-fat/fasting meal
| Study group | Role | What they receive |
|---|---|---|
| KG | Experimental | Not described Receives: Drug: VC004 Capsules |
| GK | Experimental | Not described Receives: Drug: VC004 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Day1-Day8
Peak time(Tmax)
Measured: Day1-Day8
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Measured: Day1-Day8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start20 Oct 2022
- Primary completion28 Oct 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528120
- Sponsor's protocol ID
- VC004-103
- Status last verified
- Nov 2022
- First submitted
- 1 Sep 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05528120
- Acronym / sponsor ID
- VC004-103
- Keywords
- healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed conditions in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KG | Experimental | Drug: VC004 Capsules |
| GK | Experimental | Drug: VC004 Capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (23 listed)
- More than 5 cigarettes per day on average within 3 months prior to screening;
- History of sensitivity to drugs similar to the study drug;allergic constitution (e.g. allergy to two or more kinds of drugs and food );
- 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 (> 450 mL) within 3 months prior to screening;
- History of difficulties in swallowing or any history of gastrointestinal, liver, kidney disease (whether cured or not) or surgery that affects drug absorption or excretion within 6 months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VC004 CapsulesOral administration after fasting/high-fat meal | Drug | KG |
| VC004 CapsulesOral administration after high-fat/fasting meal | Drug | GK |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day1-Day8
Peak time(Tmax)
Time frame: Day1-Day8
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time frame: Day1-Day8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VC004 Capsules in people with Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Day1-Day8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.