Carboxylesterase 1 (CES1) Genotype, CES1 Activity
Conditions
Brief summary
The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.
Interventions
DRUGMethylphenidate
10 mg as a single dose followed by one blood sample 3 hours post-dose
Sponsors
The Ministry of Science, Technology and Innovation, Denmark
Mental Health Centre Sct. Hans (Denmark)
University of Copenhagen
The Leiden Academic Center for Drug Research (LACDR)
Duke University
Bispebjerg Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years old * Caucasian
Exclusion criteria
* Chronic disease (except hay fever and eczema) * Pregnancy * Smoking * High level of alcohol consumption (\> 21 units per week for men and 14 for women) * Known allergy towards methylphenidate * Permanent use of medication (contraception ok)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of methylphenidate and ritalinic acid | Predose and 3 hours post-dose | We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolomic Profile | Predose/pre-meal, predose/post-meal and 3 hours post-dose | Three samples for each participant during the trials (as indicated above). Metabolomics will be assessed with focus on lipids (lipid platform) and with use of usual concentration measures (eg nanomolar (nM)) |
Countries
Denmark
Outcome results
None listed