An open-label study to determine the usefulness of the dried blood spot method for phenotyping and genotyping of CYP450 enzymes and the determination of trace elements in healthy volunteers.

An open-label study to determine the usefulness of the dried blood spot method for phenotyping and genotyping of CYP450 enzymes and the determination of trace elements in healthy volunteers. - Protocol 093893-CS0145: dried blood spot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35088

Enrollment

Registered

2010-03-25

Start date

2010-04-08

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Niet van toepassing Not applicable

Interventions

The study will start with a screening. At the screening the weight will be measured, a blood and urine sample will be taken for laboratory tests and an alcohol breath test and drug screen will be do

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female Age between 18-45 years

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
To compare the results of analysis of midazolam between the dried blood spot method and plasma as well as whole blood, all drawn by venipuncture.	—

Secondary

Measure	Time frame
- To compare the results of dried blood spot analysis of midazolam between blood drawn by finger prick and venous whole blood. - To compare the results of dried blood spot analysis of midazolam between using 1 and using 2 dots of the dried blood spot analysis card. - To compare the results of dried blood spot analysis of midazolam between using a 3mm and a 6 mm punch from the dried blood spot analysis card. - To evaluate the effect of storage time on the dried blood spot analysis of midazolam. - To compare genotyping of CYP3A4, CYP3A5, CYP2D6 and CYP2C19 between dried blood spots and whole blood samples. - To compare AUC of midazolam between the use of limited sampling and extensive sampling. - To investigate the feasibility of measuring 1-OH midazolam by dried blood spot analysis. - To investigate the feasibility of measuring trace elements by ICPMS from dried blood spots (exploratory). - To evaluate subject-, nurse-, and technician satisfaction of dried blood spot method versus venous blood sampling using a standardized questionnaire (exploratory).	—

Measure

Time frame

- To compare the results of dried blood spot analysis of midazolam between blood drawn by finger prick and venous whole blood. - To compare the results of dried blood spot analysis of midazolam between using 1 and using 2 dots of the dried blood spot analysis card. - To compare the results of dried blood spot analysis of midazolam between using a 3mm and a 6 mm punch from the dried blood spot analysis card. - To evaluate the effect of storage time on the dried blood spot analysis of midazolam. - To compare genotyping of CYP3A4, CYP3A5, CYP2D6 and CYP2C19 between dried blood spots and whole blood samples. - To compare AUC of midazolam between the use of limited sampling and extensive sampling. - To investigate the feasibility of measuring 1-OH midazolam by dried blood spot analysis. - To investigate the feasibility of measuring trace elements by ICPMS from dried blood spots (exploratory). - To evaluate subject-, nurse-, and technician satisfaction of dried blood spot method versus venous blood sampling using a standardized questionnaire (exploratory).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)