The primary objective of the study is to determine the effect of food on the uracil and dihydrouracil levels in plasma.Secondary objectives are:* To investigate inter- and intra-individual variations in uracil and dihydrouracil levels in plasma* To…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
onderzoek in gezonde vrijwilligers en geen geneesmiddelenonderzoek, dus niet specifiek betrekking op een aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are uracil and dihydrouracil plasma levels.
Secondary outcome
Not applicable.
Background summary
In this study it is investigated whether the intake of specific food has an
influence on uracil- and dihydrouracillevels in the blood. Uracil and
dihydrouracil are endogenous compounds of the body. These compounds can be used
as a marker for determining activity of the enzyme dihydropyrimidine
dehydrogenase (DPD). DPD plays an important role in the metabolism of specific
anti-cancer drugs (capecitabine and 5-fluorouracil). Patients with
DPD-deficiency that are treated with capecitabine or 5-fluorouracil, are at
strongly increased risk for devoloping severe, potential lethal, toxicity. For
this reason it is important to further investigate DPD and which method is best
suited for measuring DPD-activity. With this study new information will be
gathered about the effect of food on the diagnostic markers
uracil/dihydrouracil and will become clear of a fasting state or non-fasting
state is needed for determining this marker in future patients.
Study objective
The primary objective of the study is to determine the effect of food on the
uracil and dihydrouracil levels in plasma.
Secondary objectives are:
* To investigate inter- and intra-individual variations in uracil and
dihydrouracil levels in plasma
* To investigate if a fasting state is preferred for using uracil and
dihydrouracil levels in plasma as a diagnostic marker for DPD activity
Study design
Healthy volunteer food-effect studie (cross-over design)
Intervention
The intervention consists of a specific test meal (breakfast), so a fasting and
a fed state can be compared.
The breakfast is in accordance with a high-fat and high-calorie meal as
described in FDA guidances, but ingredients of the breakfast are adapted to
Dutch standards. Also, ingredients expected to have a high uracil-content are
added to the meal. See appendix I of the protocol for the composition of the
standardized test meal.
Study burden and risks
The risk for participants is small. For the determination of uracil and
dihydrouracil plasma levels, on two days 12 blood samples will be drawn. The
burden of this sampling includes one venipuncture and placing a venflon under
the skin on both days and could consist of the following side-effects:
discomfort, bruising and hematoma, and very rarely infection. On the fasting
day no food is allowed between 22:00 h and 13:00 h the following day, which can
be uncomfortable for participants.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
1. Healthy volunteer; not known with cancer or current treatment for cancer
2. Age at least 18 years
3. Able and willing to give written informed consent
4. Able and willing to consume the prescribed breakfast
5. Able and willing to undergo blood sampling
Exclusion criteria
1. Any treatment with investigational drugs within 30 days before the start of the study
2. Any condition that may interfere with the study protocol
3. Women who are pregnant
4. Allergies or intolerance for components of the prescribed breakfast
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02718664 |
| CCMO | NL56237.031.16 |