Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-01-02 @ 12:48 PM
Study NCT ID:
NCT00162461
Status:
UNKNOWN
Last Update Posted:
2018-06-12
First Post:
2005-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of CYP2C9 Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010672', 'term': 'Phenytoin'}], 'ancestors': [{'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between phenytoin metabolic ratio and CYP2C9 genotype', 'timeFrame': '24 hours'}, {'measure': 'Frequency distribution of phenytoin metabolic ratio in the population', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'keywords': ['Healthy Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9.\n\nThe purpose of the present study is:\n\n1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity\n2. To correlate phenytoin metabolic ratio with CYP2C9 genotype\n3. To study the frequency distribution of CYP2C9 activity in-vivo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range of 20-50 years old\n* Absence of significant disease states\n\nExclusion Criteria:\n\n* The presence of significant disease states\n* The use of drugs (including birth control pills)'}, 'identificationModule': {'nctId': 'NCT00162461', 'briefTitle': 'Evaluation of CYP2C9 Activity', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity In-vivo', 'orgStudyIdInfo': {'id': 'yc19559-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenytoin', 'interventionNames': ['Drug: Phenytoin single dose (300 mg)']}], 'interventions': [{'name': 'Phenytoin single dose (300 mg)', 'type': 'DRUG', 'armGroupLabels': ['Phenytoin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arik Tzukert, DMD', 'role': 'CONTACT', 'email': 'arik@hadassah.org.il', 'phone': '00 972 2 6776095'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}, {'name': 'Yoseph Caraco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Yoseph Caraco, MD', 'role': 'CONTACT', 'email': 'caraco@hadassah.org.il', 'phone': '00 972 2 6778584'}], 'overallOfficials': [{'name': 'Yoseph Caraco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States - Israel Binational Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}