Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00427505
Status:
COMPLETED
Last Update Posted:
2009-11-19
First Post:
2007-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077588', 'term': 'Deferasirox'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2007-01-25', 'studyFirstSubmitQcDate': '2007-01-26', 'lastUpdatePostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of deferasirox on the pharmacokinetics of midazolam'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by adverse events (AEs)'}]}, 'conditionsModule': {'keywords': ['Interaction', 'healthy volunteers', 'deferasirox', 'midazolam'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a study to investigate the pharmacokinetics of deferasirox'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good health\n* No evidence of iron deficiency\n* Weight between 50 and 100 kg\n* Body Mass Index between 19 and 29 kg/m2\n\nExclusion Criteria:\n\n* Use of certain drugs, herbal remedies or nutrients\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00427505', 'briefTitle': 'Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CICL670A2126'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Deferasirox', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'e', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}