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OpenTrials
Completed

NCT Number: NCT02718664

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

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

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Key information

Conditions

Drug Safety Biomarkers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Netherlands Cancer Institute

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer; not known with cancer or current treatment for cancer
  • Age at least 18 years
  • Able and willing to give written informed consent
  • Able and willing to consume the prescribed breakfast
  • Able and willing to undergo blood sampling

Exclusion criteria

  • Any treatment with investigational drugs within 30 days before the start of the study
  • Any condition that may interfere with the study protocol
  • Women who are pregnant
  • Allergies or intolerance for components of the prescribed breakfast

Treatment and study plan

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

Primary outcomes

  1. Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition

    Time frame: 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 outcomes

  1. dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)

    Time frame: baseline

    Dihydropyrimidine dehydrogenase enzyme activity is assessed at baseline to rule out any potential influence of dihydropyrimidine dehydrogenase deficiency on uracil and dihydrouracil levels

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2016
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.