Individualised drug therapy based on pharmacogenomics: focus on carboxylesterase 1 (CES1) - INDICES/WP2
- Conditions
- Healthy volunteers with special genotypesMedDRA version: 16.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 100000004848Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2011-004815-22-DK
- Lead Sponsor
- Research Institute of Biological Psychiatry Sct. Hans
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy volunteers of both sexes
Age > 18 y
Caucasian race
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Any chronic disease
Infection within the last 14 days
Pregnancy
Regular use of medication
Smoking
Alcohol intake
Known allergy to methylphenidate or trandolpril
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Impact of different CES1 genotypes on the metabolism of methylphenidate and trandolapril;Secondary Objective: Can metabolomic profiling reduce the variation in the metabolism of methylphenidate and trandolapril;Primary end point(s): Pharmacokinetic variables after administration of single doses of methylphenidate and trandolapril to healthy volunteers with different CES1 genotypes;Timepoint(s) of evaluation of this end point: Two to 3 days after single dose administration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No