NCT02718664CompletedNot Applicable
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
The Netherlands Cancer Institute1 site in 1 country16 target enrollmentStarted: April 14, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition
Study Overview
Brief Summary
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
B (fed)
Experimental
Fed condition (test meal)
Intervention: Test meal (breakfast) (Other)
A (fasting)
No Intervention
Fasting condition
Outcomes
Primary Outcomes
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
- dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)(baseline)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Food-effect study on uracil and dihydrouracil levels as a diagnostic marker of DPD activitystudy on markers for dihydropyrimidine dehydrogenase-activityonderzoek in gezonde vrijwilligers en geen geneesmiddelenonderzoek, dus niet specifiek betrekking op een aandoeninguracil and dihydrouracil levels as diagnostic markerNL-OMON46108Antoni van Leeuwenhoek Ziekenhuis16
Completed
Phase 1
A Food-Drug Interaction Study of Serum Urate After Oral InosineHealthyNCT02614469Michael Alan Schwarzschild18
Completed
Not Applicable
Physiological effects of uridine on food intakeHealthy VolunteersDRKS00014874Max-Planck-Institut für Stoffwechselforschung37
Completed
Phase 1
A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult SubjectsSolid TumorNCT05440006Jiangsu HengRui Medicine Co., Ltd.20
Completed
Not Applicable
A study to investigate effects of study food substance on lowering blood pressure: a verification studyHigh-normal blood pressure and Grade 1 hypertension patientsJPRN-UMIN000028384CROee.INC24