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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-14

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Drug Safety Biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A (fasting)

Fasting condition

Group Type NO_INTERVENTION

No interventions assigned to this group

B (fed)

Fed condition (test meal)

Group Type EXPERIMENTAL

Test meal (breakfast)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes