Determination of the individual genotypes for drug metabolizing enzymes and transporters among volunteers, in order to design dedicated clinical trials in a subpopulation, for (potential new) drugs that are substrates, inducers or inhibitors of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pharmacogenetics
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Distribution of genotype of p-Gp, BCRP, OATP1B1, OATP1B, OAT1, OAT3, OCT1,
OCT2, MATE1, 5-HTTLPR, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
Secondary outcome
N.ap.
Background summary
This study entails the collection of a blood sample of volunteers for
genotyping metabolic enzymes and drug transporters, in order to have insight in
the distribution of the various genotypes for drug metabolizing enzymes and
transporters among the volunteer*s pool of QPS.
Within drug development it is increasingly recognized by regulatory bodies that
one of the reasons for the inter-subject variation in the pharmacokinetics of a
(potential new) drug is the genotype of metabolizing enzymes or drug
transporters.
Study objective
Determination of the individual genotypes for drug metabolizing enzymes and
transporters among volunteers, in order to design dedicated clinical trials in
a subpopulation, for (potential new) drugs that are substrates, inducers or
inhibitors of particular metabolic enzymes or transporters.
Study design
A prospective, observational cohort study.
Study burden and risks
The burden for participants is a single blood sample of 20 mL. No additional
venepuncture is needed, this sampling only concerns additional tubes.
Petrus Campersingel 123
Groningen 9713 AG
NL
Petrus Campersingel 123
Groningen 9713 AG
NL
Listed location countries
Age
Inclusion criteria
1. Provision of written informed consent.
2. Male and female subjects aged >=18 years.
Exclusion criteria
1. Previous participation in the current screening protocol.
2. The subject is, in the opinion of the Investigator, unlikely to comply with
the protocol or considered unsuitable for this study. For instance, when
drawing 20 mL of blood is exclusionary for a planned participation in a QPS
clinical trial.
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 | NL71021.056.19 |