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

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 14, 2016

Primary Completion Date

June 1, 2017

Study Completion Date

December 31, 2017

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

Trial Locations (1)

Unknown

The Netherlands Cancer Institute, Amsterdam

All Listed Sponsors
lead

The Netherlands Cancer Institute

OTHER

NCT02718664 - Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity | Biotech Hunter | Biotech Hunter