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

Not Applicable

• Conditions: Drug Safety Biomarkers
• Interventions: Other: Test meal (breakfast)

• Registration Number: NCT02718664
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Study Start: 2016-04
• Primary Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B (fed)	Test meal (breakfast)	Fed condition (test meal)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands