Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-07 @ 3:03 PM
Study NCT ID:
NCT02231450
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2014-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2014-09-01', 'studyFirstSubmitQcDate': '2014-09-03', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)', 'timeFrame': '0 to 96 hours'}, {'measure': 'Maximum observed plasma concentration (Cmax) of Lu AE58054', 'timeFrame': '0 to 96 hours'}], 'secondaryOutcomes': [{'measure': 'Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)', 'timeFrame': 'Screening to day 11'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AE58054', 'Hepatic impairment'], 'conditions': ['Heptic Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).\n* Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)\n* Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)\n* Group 3: Healthy subjects with normal hepatic function\n\nOther pre-defined inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT02231450', 'briefTitle': 'Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects', 'orgStudyIdInfo': {'id': '15877A'}, 'secondaryIdInfos': [{'id': '2013-004449-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with mild hepatic impairment (Group1)', 'description': '8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054', 'interventionNames': ['Drug: Lu AE58054 encapsulated film-coated tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with moderate hepatic impairment (Group 2)', 'description': '8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.', 'interventionNames': ['Drug: Lu AE58054 encapsulated film-coated tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy subjects (Group 3)', 'description': '8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.', 'interventionNames': ['Drug: Lu AE58054 encapsulated film-coated tablets']}], 'interventions': [{'name': 'Lu AE58054 encapsulated film-coated tablets', 'type': 'DRUG', 'armGroupLabels': ['Healthy subjects (Group 3)', 'Patients with mild hepatic impairment (Group1)', 'Patients with moderate hepatic impairment (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'country': 'Germany', 'facility': 'APEX GmbH', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], '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'}}}}