Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01122667
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2010-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'C530884', 'term': 'anacetrapib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC(0 to infinity)) of anacetrapib', 'timeFrame': 'through 168 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events', 'timeFrame': 'through 14 days post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal Insufficiency'], 'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '24782116', 'type': 'RESULT', 'citation': 'Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study\n* Subject is in good health\n* If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day\n\nExclusion Criteria:\n\n* Subject has a history of stroke, chronic seizures or major neurological disorder\n* Subject has a history of cancer\n* Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study\n* Subject consumes excessive amounts of alcohol or caffeine\n* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks\n* Subject is a nursing mother\n* Subject has had a kidney removed or has a functioning renal transplant'}, 'identificationModule': {'nctId': 'NCT01122667', 'briefTitle': 'Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function', 'orgStudyIdInfo': {'id': '0859-038'}, 'secondaryIdInfos': [{'id': 'MK0859-038'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - Panel A', 'description': 'Subjects with severe renal impairment', 'interventionNames': ['Drug: anacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - Panel B', 'description': 'Healthy matched control subjects', 'interventionNames': ['Drug: anacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Panel C', 'description': 'Subjects with moderate renal impairment', 'interventionNames': ['Drug: anacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Panel D', 'description': 'Healthy matched control subjects', 'interventionNames': ['Drug: anacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Panel E', 'description': 'Subjects with mild renal impairment', 'interventionNames': ['Drug: anacetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Panel F', 'description': 'Healthy matched control subjects', 'interventionNames': ['Drug: anacetrapib']}], 'interventions': [{'name': 'anacetrapib', 'type': 'DRUG', 'description': 'single dose administration of anacetrapib (MK0859) 100 mg oral tablet', 'armGroupLabels': ['Part 1 - Panel A', 'Part 1 - Panel B', 'Part 2 - Panel C', 'Part 2 - Panel D', 'Part 2 - Panel E', 'Part 2 - Panel F']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}