The objective of this research is to compare the results of the analysis of midazolam between the dried blood spot method, plasma and whole blood.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Niet van toepassing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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).
Background summary
With this study Xendo will determine the usefulness of the so-called dried
blood spot method for taking blood samples and processing of blood samples for
analysis of midazolam, for for phenotyping and genotyping liver enzymes and the
determination of trace elements.
Study objective
The objective of this research is to compare the results of the analysis of
midazolam between the dried blood spot method, plasma and whole blood.
Study design
This study is an open-label study in 12 healthy subjects. After assessing
eligibility the subjects will come to the clinic1 h pre-dose. The subjects
will receive a single dose of midazolam of 7,5 mg. During this day bloodsamples
will be taken until 12h post dose by a venous canula or finger prick.
Intervention
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 done.
During the stay in the clinic the subject will receive 7.5 mg midazolam.
Furthermore blood will be taken frequently and an alcohol breath test and drug
screen will be done. Two questionairres will be filled in as well.
Study burden and risks
The drug midazolam is well tolerated in general. There were some adverse events
reported in relation with the drug. These were dizziness, headache and
drowsiness. The expectation is that the drowsiness is ended when the subjects
leave the clinic, if not the subject will stay for one night in the clinic.
Based on many years of experience from midazolam as a drug the current dose is
chosen. The risks with these doses is likely to be minimal, but as with all
clinical drug studies, unforeseeable adverse reactions could occur.
Blood sampling is not dangerous, but can be sensitive or cause bruising.
Rarely, fainting or a local inflammation occurs at the place of sampling.
Hanzeplein 1 - Entrance 53
9713 GZ Groningen
The Netherlands
Hanzeplein 1 - Entrance 53
9713 GZ Groningen
The Netherlands
Listed location countries
Age
Inclusion criteria
Healthy male and female
Age between 18-45 years
Exclusion criteria
Clinical significant abnormalities at medical research
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31394.056.10 |