Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-25 @ 6:34 PM
Study NCT ID:
NCT02122692
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2014-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C568612', 'term': '(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine'}, {'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)', 'timeFrame': 'Day 5 and Day 11'}, {'measure': 'Maximum observed concentration (Cmax) of Lu AE58054', 'timeFrame': 'Day 5 and Day 11'}], 'secondaryOutcomes': [{'measure': 'Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F', 'timeFrame': 'Day 5 and Day 11'}, {'measure': 'Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)', 'timeFrame': 'Day 5 and Day 11'}, {'measure': 'Plasma pharmacokinetic parameters for itraconazole: CTrough', 'timeFrame': 'Day 6 to Day 13'}, {'measure': 'Adverse events', 'timeFrame': 'Up to Day 18, including a safety follow-up'}, {'measure': 'Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions', 'timeFrame': 'Up to Day 18, including a safety follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects are eligible for inclusion into the study if they meet each of the following criteria:\n\n* Men and women, aged 18 - 45 years.\n* Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.\n* Good general health ascertained by a detailed medical history, laboratory tests and physical examination.\n* Non-childbearing potential or use of contraception (both sexes).\n* Women must not be pregnant or lactating.\n* Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .\n\nOther Inclusion and Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02122692', 'briefTitle': 'Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects', 'orgStudyIdInfo': {'id': '15820A'}, 'secondaryIdInfos': [{'id': '2013-003597-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AE58054 30 mg + itraconazole 200 mg', 'interventionNames': ['Drug: Lu AE58054 30 mg', 'Drug: Lu AE58054 30 mg + itraconazole 200 mg', 'Drug: Itraconazole']}], 'interventions': [{'name': 'Lu AE58054 30 mg', 'type': 'DRUG', 'description': 'Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally', 'armGroupLabels': ['Lu AE58054 30 mg + itraconazole 200 mg']}, {'name': 'Lu AE58054 30 mg + itraconazole 200 mg', 'type': 'DRUG', 'description': 'Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally', 'armGroupLabels': ['Lu AE58054 30 mg + itraconazole 200 mg']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Itraconazole capsules, once daily, Day 12-13, orally', 'armGroupLabels': ['Lu AE58054 30 mg + itraconazole 200 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'FR801', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}