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

Drug Safety Biomarkers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02718664
• Other study ID #: N16URA
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2016
• Last updated: August 16, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Safety Biomarkers

Intervention

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

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uracil levels (ng/ml) and dihydrouracil levels (ng/ml), compared in fed and fasting condition	12 blood samples taken on both test days (fed and fasting condition), to investigate the effect of food on uracil and dihydrouracil levels	2 test days
Secondary	dihydropyrimidine dehydrogenase enzyme activity (nmol/mg*h)	Dihydropyrimidine dehydrogenase enzyme activity is assessed at baseline to rule out any potential influence of dihydropyrimidine dehydrogenase deficiency on uracil and dihydrouracil levels	baseline