Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
Phase 4
Completed
- Conditions
- Carboxylesterase 1 (CES1) GenotypeCES1 Activity
- Interventions
- Registration Number
- NCT02135263
- 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 two CES1 dependent drugs, enalapril and methylphenidate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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 and enalapril
- Permanent use of medication (contraception ok)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Methylphenidate Methylphenidate - Enalapril Enalapril -
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of enalapril Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose Peak plasma concentration (Cmax) of methylphenidate Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose Time to peak plasma concentration (Tmax) of methylphenidate Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose Terminal half life (t½) of methylphenidate Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose Area under the plasma concentration versus time curve (AUC) of methylphenidate Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose Time to peak plasma concentration (Tmax) of enalapril Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose Terminal half life (t½) of enalapril Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose Area under the plasma concentration versus time curve (AUC) of enalapril Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
- Secondary Outcome Measures
Name Time Method Metabolomic profile Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose Four samples for each participant during the methylphenidate 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