Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02147535
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2014-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of CES1 Genotype on Metabolism of Methylphenidate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-10', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-05-22', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of methylphenidate and ritalinic acid', 'timeFrame': 'Predose and 3 hours post-dose', 'description': 'We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity.'}], 'secondaryOutcomes': [{'measure': 'Metabolomic Profile', 'timeFrame': 'Predose/pre-meal, predose/post-meal and 3 hours post-dose', 'description': '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))'}]}, 'conditionsModule': {'conditions': ['Carboxylesterase 1 (CES1) Genotype', 'CES1 Activity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* Caucasian\n\nExclusion Criteria:\n\n* Chronic disease (except hay fever and eczema)\n* Pregnancy\n* Smoking\n* High level of alcohol consumption (\\> 21 units per week for men and 14 for women)\n* Known allergy towards methylphenidate\n* Permanent use of medication (contraception ok)'}, 'identificationModule': {'nctId': 'NCT02147535', 'briefTitle': 'Impact of CES1 Genotype on Metabolism of Methylphenidate', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Impact of CES1 Genotype on Metabolism of Methylphenidate', 'orgStudyIdInfo': {'id': 'INDICES-WP2-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylphenidate', 'interventionNames': ['Drug: Methylphenidate']}], 'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'otherNames': ['Ritalin'], 'description': '10 mg as a single dose followed by one blood sample 3 hours post-dose', 'armGroupLabels': ['Methylphenidate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Clinical Pharmacology, Bispebjerg University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Claus Stage, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology, Bispebjerg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}, {'name': 'Mental Health Centre Sct. Hans (Denmark)', 'class': 'UNKNOWN'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'The Leiden Academic Center for Drug Research (LACDR)', 'class': 'UNKNOWN'}, {'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Claus Stage', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}