Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 11:05 AM
Study NCT ID:
NCT01537757
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2012-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613570', 'term': 'verubecestat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2012-02-17', 'studyFirstSubmitQcDate': '2012-02-17', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931', 'timeFrame': 'Predose through 120 hours post single dose of MK-8931'}], 'secondaryOutcomes': [{'measure': 'Renal clearance (CLr) of MK-8931', 'timeFrame': 'Predose through 120 hours post single dose of MK-8931'}, {'measure': 'Fraction of MK-8931 dose excreted in urine (fe)', 'timeFrame': 'Predose through 120 hours post single dose of MK-8931'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in participants with severe renal disease and in healthy matched control participants will be studied. If data from Part 1 confirms that severe renal impairment does not alter the pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study will be required and Part 2 will be optional. If the data does not support this conclusion, then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with moderate and mild renal impairment compared to healthy matched controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index ≤39 kg/m\\^2\n* No clinically significant abnormality on electrocardiogram\n* Female participant must be postmenopausal or surgically sterilized\n* Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 3 months after stopping the medication\n\nInclusion Criteria Specific to Renally Impaired Participants:\n\n* Clinical diagnosis of renal insufficiency based on Estimated Glomerular Filtration rate (eGFR): severely decreased eGFR, defined as \\<30 mL/min/1.73m\\^2 and participant is not on dialysis; moderately decreased eGFR, defined as ≥30 to \\<60 mL/min/1.73m\\^2; mildly decreased eGFR, defined as ≥60 to \\<80 mL/min/1.73m\\^2\n* Stable baseline health based on medical history, physical examination, vital signs, and laboratory tests\n\nInclusion Criterion Specific to Healthy Participants:\n\n* eGFR ≥80 mL/min/1.73m\\^2\n\nExclusion Criteria:\n\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug, including history or presence of inflammatory bowel disease, gastrointestinal or rectal bleeding; presence of active ulcer; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; history of pancreatic injury or pancreatitis; history or presence of liver disease or liver injury; history of urinary obstruction or difficulty in voiding\n* History of any infectious disease within 4 weeks prior to drug administration\n* Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV)\n* History of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of Long QT Syndrome)\n* Participant has had a kidney removed or has a functioning renal transplant\n* History of alcohol or drug abuse in the past 2 years\n* Blood donation or loss of significant volume of blood in the past 60 days prior to dosing\n* Previously received MK-8931\n* History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n* History of malignancy occurring within the 5 years immediately before screening, except for a participant who has been adequately treated for basal cell or squamous cell skin cancer; or in situ cervical cancer; or\n\nlocalized prostate carcinoma; or has undergone potentially curative therapy with no evidence of recurrence ≥1 year post-therapy\n\nExclusion Criteria Specific to Renally Impaired Participants:\n\n* Rapidly fluctuating renal function as determined by historical measurements\n* Suspected renal artery stenosis'}, 'identificationModule': {'nctId': 'NCT01537757', 'briefTitle': 'A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (Protocol No. MK-8931-009 [P08535])', 'orgStudyIdInfo': {'id': 'P08535'}, 'secondaryIdInfos': [{'id': 'MK-8931-009', 'type': 'OTHER', 'domain': 'Schering -Plough'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1, Panel A - Severe Renal Impairment Group', 'interventionNames': ['Drug: MK-8931']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Panel B - Healthy Control Group to Match Panel A', 'interventionNames': ['Drug: MK-8931']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Panel C - Moderate Renal Impairment Group', 'interventionNames': ['Drug: MK-8931']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Panel D - Healthy Control Group to Match Panel C', 'interventionNames': ['Drug: MK-8931']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Panel E - Mild Renal Impairment Group', 'interventionNames': ['Drug: MK-8931']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Panel F - Healthy Control Group to Match Panel E', 'interventionNames': ['Drug: MK-8931']}], 'interventions': [{'name': 'MK-8931', 'type': 'DRUG', 'description': 'Single dose, administered as oral capsules', 'armGroupLabels': ['Part 1, Panel A - Severe Renal Impairment Group', 'Part 1, Panel B - Healthy Control Group to Match Panel A', 'Part 2, Panel C - Moderate Renal Impairment Group', 'Part 2, Panel D - Healthy Control Group to Match Panel C', 'Part 2, Panel E - Mild Renal Impairment Group', 'Part 2, Panel F - Healthy Control Group to Match Panel E']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}