Impact of CES1 Genotype on Metabolism of Methylphenidate
Phase 4
Completed
- Conditions
- CES1 ActivityCarboxylesterase 1 (CES1) Genotype
- Interventions
- Registration Number
- NCT02147535
- Lead Sponsor
- Bispebjerg Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Methylphenidate Methylphenidate -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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))
Trial Locations
- Locations (1)
Department of Clinical Pharmacology, Bispebjerg University Hospital
🇩🇰Copenhagen, Denmark