Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-30 @ 12:08 AM
Study NCT ID:
NCT01340456
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2011-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cholesterol Metabolites as Markers for CYP3A Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-08', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-20', 'lastUpdatePostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 4beta-OHcholesterol', 'timeFrame': 'Directly before treatment with rifampicin and 14 days after the end of treatment with rifampicin', 'description': 'The primary objective of the study is to investigate whether the endogenous cholesterol metabolite 4β-hydroxycholesterol could be used as a marker for induction of CYP3A4. For this purpose the induction of 4β-hydroxycholesterol formation will be compared to the induction of quinine and midazolam metabolism.'}], 'secondaryOutcomes': [{'measure': 'Ratio between midazolam AUC induced and midazolam AUC uninduced', 'timeFrame': 'Before treatment with rifampicin and after 14 days of treatment with rifampicin', 'description': 'Secondary aim of the study is to compare 4β-hydroxycholesterol as a biomarker for CYP3A4 compared to 6β-hydroxycortisol/cortisol ratio, which sometimes is used as a marker for CYP3A4 induction.\n\nAnother secondary aim is to relate our estimations of CYP3A4-expression to measured levels of 25-OH-vitamin D.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['4beta-OHcholesterol', 'Midazolam', 'CYP3A4', 'Enzyme induction', 'Drug metabolism'], 'conditions': ['CYP3A4 Induction']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n* To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be used as a marker for induction of cytochrome P450 (CYP) 3A4.\n* To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females and males.\n2. Age of 18 and above.\n3. Caucasians.\n4. Healthy as assessed by medical history and examination by principal investigator or delegated personnel.\n5. Accept to refrain from herbal drugs, natural preparations, and grapefruit juice 48 hours before and during the study period.\n6. Accept to completely refrain from alcohol during day -1 to 1 and R14-R16. During the rest of the study moderate alcohol use is permitted (equal to 1 glass of wine or 1 beer per day).\n7. Women of childbearing age should accept using a reliable barrier contraceptive method throughout the study.\n8. Women of childbearing age should have a negative pregnancy test at the screening visit.\n9. Capable of following given instructions.\n10. Has given written informed consent after receiving both oral and written study information.\n\nExclusion Criteria:\n\n1. Predisposal to allergic drug reactions.\n2. Anamnestic and/or visual signs of infection.\n3. Women are not allowed to use oral hormone-based contraceptives 2 weeks before start of study and during the study.\n4. Participation in another study within one month before entering the present study.\n5. Intake of any other drug that can influence the enzyme activity of CYP3A4.\n6. Pregnancy.\n7. Breast-feeding.\n8. A history of liver disease.'}, 'identificationModule': {'nctId': 'NCT01340456', 'briefTitle': 'Cholesterol Metabolites as Markers for CYP3A Induction', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Induction of Drug Metabolism by Rifampicin to Compare the Endogenous Biomarker 4beta-OHcholesterol With the Probe Drug Midazolam as Quantitative Markers for Cytochrome P450 3A4 Induction', 'orgStudyIdInfo': {'id': '1001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifampicin 10 mg QD', 'interventionNames': ['Drug: Rifampicin treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Rifampicin 20 mg QD', 'interventionNames': ['Drug: Rifampicin treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Rifampicin 100 mg QD', 'interventionNames': ['Drug: Rifampicin treatment']}], 'interventions': [{'name': 'Rifampicin treatment', 'type': 'DRUG', 'otherNames': ['Rifadin'], 'description': 'induction of CYP3A4 with one of three rifampicin doses (10, 20, 100 mg QD)', 'armGroupLabels': ['Rifampicin 10 mg QD', 'Rifampicin 100 mg QD', 'Rifampicin 20 mg QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Clinical Pharmacology Trial Unit (CPTU), Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Tobias Bäckström, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology, Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Tobias Bäckström', 'oldOrganization': 'Department of Clinical Pharmacology, Karolinska University Hospital'}}}}