Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-01 @ 4:58 AM
Study NCT ID:
NCT02340195
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2015-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568612', 'term': '(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-06', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)', 'timeFrame': 'Day 10'}, {'measure': 'Maximum observed concentration (Cmax) of Lu AE58054', 'timeFrame': '0-12 hours day 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kidney impairment'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged between 50 and 75 years (inclusive)\n* BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.\n* Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)\n* Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)\n* Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)\n* Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)\n\nExclusion Criteria:\n\n•The subject has taken disallowed medication \\<1 week prior to the first dose of IMP or \\<5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)\n\nOther protocol defined inclusion and exclusion criteria do apply'}, 'identificationModule': {'nctId': 'NCT02340195', 'briefTitle': 'Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects', 'orgStudyIdInfo': {'id': '14916A'}, 'secondaryIdInfos': [{'id': '2012-005647-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Idalopirdine (Lu AE58054) 60 mg (Group A)', 'description': '8 patients with severe renal impairment and not on dialysis', 'interventionNames': ['Drug: Idalopirdine (Lu AE58054) 60 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Idalopirdine (Lu AE58054) 60 mg (Group B)', 'description': '8 healthy subjects', 'interventionNames': ['Drug: Idalopirdine (Lu AE58054) 60 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Idalopirdine (Lu AE58054) 60 mg (Group C)', 'description': 'Group C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B\n\n8 patients with moderate renal impairment', 'interventionNames': ['Drug: Idalopirdine (Lu AE58054) 60 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Idalopirdine (Lu AE58054) 60 mg (Group D)', 'description': 'Group D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B\n\n8 patients with mild renal impairment', 'interventionNames': ['Drug: Idalopirdine (Lu AE58054) 60 mg']}], 'interventions': [{'name': 'Idalopirdine (Lu AE58054) 60 mg', 'type': 'DRUG', 'description': 'encapsulated film-coated tablets for oral use once daily for 10 days', 'armGroupLabels': ['Idalopirdine (Lu AE58054) 60 mg (Group A)', 'Idalopirdine (Lu AE58054) 60 mg (Group B)', 'Idalopirdine (Lu AE58054) 60 mg (Group C)', 'Idalopirdine (Lu AE58054) 60 mg (Group D)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'country': 'Germany', 'facility': 'DE801', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}