Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-05 @ 7:18 PM
Study NCT ID:
NCT01934166
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2013-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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': 'C038981', 'term': 'nalmefene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For nalmefene: apparent volume of distribution for nalmefene (Vz /F)', 'timeFrame': 'Up to 120 hours post-dose'}, {'measure': 'For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent', 'timeFrame': 'Up to 120 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'Up to 10 days', 'description': 'Number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-\\<50 ml/min/1.73m2, \\<30 ml/min/1.73m2 will be included in the study.\n* The subjects must have a BMI between 19 and 32 kg/m2.\n\nExclusion Criteria:\n\n* The subject has a history of renal transplant or is undergoing dialyse treatment.\n* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.\n\nOther inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01934166', 'briefTitle': 'Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects', 'orgStudyIdInfo': {'id': '15084A'}, 'secondaryIdInfos': [{'id': '2012-005711-53', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nalmefene 18 mg', 'description': '18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride', 'interventionNames': ['Drug: Nalmefene 18 mg']}], 'interventions': [{'name': 'Nalmefene 18 mg', 'type': 'DRUG', 'otherNames': ['Selincro®'], 'description': 'One single oral dose of 18 mg', 'armGroupLabels': ['Nalmefene 18 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81241', 'city': 'Munich', 'country': 'Germany', 'facility': 'DE801', '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'}}}}