Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-14 @ 8:21 AM
Study NCT ID:
NCT02329405
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2014-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of PXR Activation on Hepatic Fat Content
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2014-12-30', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic fat fraction', 'timeFrame': 'Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '35229613', 'type': 'DERIVED', 'citation': 'Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.'}]}, 'descriptionModule': {'briefSummary': "This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Body mass index (BMI) 18.5-25 kg/m2\n\nExclusion Criteria:\n\n* Systolic blood pressure over 150 mmHg\n* Any continuous medication (hormonal intrauterine device is permitted)\n* Any significant medical condition\n* Insensitivity to rifampicin\n* Pregnancy and lactation\n* Previous difficult venipuncture\n* Alcohol and medicine abuse and drug use\n* Participation to any other pharmaceutical trial within on month of screening\n* Claustrophobia\n* Metal and other implants which are contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT02329405', 'briefTitle': 'The Effects of PXR Activation on Hepatic Fat Content', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'PXR-aktivaation Vaikutus Maksan Rasvoittumiseen', 'orgStudyIdInfo': {'id': 'Rifa-Stea'}, 'secondaryIdInfos': [{'id': '2014-003422-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifampicin', 'description': 'Rifampicin 600 mg tablet once a day orally for a week.', 'interventionNames': ['Drug: Rifampicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet once a day orally for a week.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rifampicin', 'type': 'DRUG', 'otherNames': ['Rifampin'], 'armGroupLabels': ['Rifampicin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90029 OYS', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Janne Hukkanen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}