Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Drug Safety Biomarkers

Treatments: Other: Test meal (breakfast)

Study type: Interventional

Funder types: Other

Identifiers

NCT02718664

N16URA

Details and patient eligibility

About

Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

A (fasting)

No Intervention group

Description:

Fasting condition

B (fed)

Experimental group

Description:

Fed condition (test meal)

Treatment:

Other: Test meal (breakfast)