Drug Safety BiomarkersNCT02718664
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
A study testing Test meal (breakfast) in people with Drug Safety Biomarkers, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Safety Biomarkers
- What is being tested?
- Test meal (breakfast)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Apr 2016to Dec 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer; not known with cancer or current treatment for cancer
- Age at least 18 years
- Able and willing to give written informed consent
- Able and willing to consume the prescribed breakfast
- Able and willing to undergo blood sampling
Who cannot join
- Any treatment with investigational drugs within 30 days before the start of the study
- Any condition that may interfere with the study protocol
- Women who are pregnant
- Allergies or intolerance for components of the prescribed breakfast
Trial locations and contacts
1 site in 1 country.
About this study
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
- Conditions
- Drug Safety Biomarkers
- Being tested
- Test meal (breakfast)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal (breakfast)Other
Standardized test meal, in accordance with high-fat and high-calorie meal as described in the FDA guidance, but ingredients are changed to Dutch standards and ingredients are added that are expected to have the largest effects on dihydrouracil and uracil levels
| Study group | Role | What they receive |
|---|---|---|
| A (fasting) | No intervention | Fasting condition |
| B (fed) | Experimental | Fed condition (test meal) Receives: Other: Test meal (breakfast) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
12 blood samples taken on both test days (fed and fasting condition), to investigate the effect of food on uracil and dihydrouracil levels
Measured: 2 test days
Secondary outcomes (1)
dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)
Dihydropyrimidine dehydrogenase enzyme activity is assessed at baseline to rule out any potential influence of dihydropyrimidine dehydrogenase deficiency on uracil and dihydrouracil levels
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start14 Apr 2016
- Primary completion1 Jun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Safety BiomarkersStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Schellens, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718664
- Sponsor's protocol ID
- N16URA
- Status last verified
- Aug 2017
- First submitted
- 24 Feb 2016
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
- ClinicalTrials.gov ID
- NCT02718664
- Acronym / sponsor ID
- N16URA
- Conditions
- Drug Safety Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (fasting) | No intervention | –Fasting condition |
| B (fed) | Experimental | Other: Test meal (breakfast)Fed condition (test meal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteer; not known with cancer or current treatment for cancer
- Age at least 18 years
- Able and willing to give written informed consent
- Able and willing to consume the prescribed breakfast
- Able and willing to undergo blood sampling
Key exclusion criteria (4 listed)
- Any treatment with investigational drugs within 30 days before the start of the study
- Any condition that may interfere with the study protocol
- Women who are pregnant
- Allergies or intolerance for components of the prescribed breakfast
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 |
|---|---|---|
| Test meal (breakfast)Standardized test meal, in accordance with high-fat and high-calorie meal as described in the FDA guidance, but ingredients are changed to Dutch standards and ingredients are added that are expected to have the largest effects on dihydrouracil and uracil levels | Other | B (fed) |
Primary outcome
Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
Time frame: 2 test days
12 blood samples taken on both test days (fed and fasting condition), to investigate the effect of food on uracil and dihydrouracil levels
1 secondary outcome
dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)
Time frame: baseline
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 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jan Schellens, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal (breakfast) in people with Drug Safety Biomarkers, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 4 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 3 Aug 2025. 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 Netherlands. 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.
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?
Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition (time frame: 2 test days). 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 3 Aug 2025.