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| Name | Class |
|---|---|
| The Ministry of Science, Technology and Innovation, Denmark | OTHER_GOV |
| Mental Health Centre Sct. Hans (Denmark) | UNKNOWN |
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Experimental |
| |
| Enalapril | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | 10 mg as a single dose followed by blood samples for the next 33 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Peak plasma concentration (Cmax) of enalapril | Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolomic profile | 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)) | Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gesche Jürgens, M.D. | Department of Clinical Pharmacology, Bispebjerg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Bispebjerg University Hospital | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| The Leiden Academic Center for Drug Research (LACDR) |
| UNKNOWN |
| Duke University | OTHER |
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| Enalapril | Drug | 10 mg as a single dose followed by blood samples for the next 72 hours |
|
|
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |