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Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (fasting) | No Intervention | Fasting condition | |
| B (fed) | Experimental | Fed condition (test meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 test days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Schellens, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Netherlands Cancer Institute | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D062407 | Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| D019602 |
| Food and Beverages |