MedTrace Logo

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

NCT02718664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-03

No results posted yet for this study

Summary

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

Conditions

  • Drug Safety Biomarkers

Interventions

OTHER

Test 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 & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Jan Schellens, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2017-06-01
Completion
2017-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718664 on ClinicalTrials.gov