Drug Safety Biomarkers
Conditions
Brief summary
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
Interventions
OTHERTest 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
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h) | baseline | Dihydropyrimidine dehydrogenase enzyme activity is assessed at baseline to rule out any potential influence of dihydropyrimidine dehydrogenase deficiency on uracil and dihydrouracil levels |
Countries
Netherlands
Outcome results
None listed