Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:37 AM
Study NCT ID:
NCT07334860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2025-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Compare Forms of MK-1167 in Healthy People (MK-1167-011)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2025-12-31', 'studyFirstSubmitQcDate': '2025-12-31', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-1167.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the Cmax of MK-1167.'}, {'measure': 'Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-1167.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 24 hours)', 'description': 'Blood samples will be collected to determine the AUC0-24 of MK-1167.'}, {'measure': 'Concentration at 24 hours (C24) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 24 hours)', 'description': 'Blood samples will be collected to determine the C24 of MK-1167.'}, {'measure': 'Time to Maximum Serum Concentration (Tmax) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the Tmax of MK-1167.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the t1/2 of MK-1167.'}, {'measure': 'Apparent Clearance after Nonintravenous Administration (CL/F) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the CL/F of MK-1167.'}, {'measure': 'Apparent Volume of Distribution during Terminal Phase (Vz/F) of MK-1167', 'timeFrame': 'At designated time points (up to approximately 21 days)', 'description': 'Blood samples will be collected to determine the Vz/F of MK-1167.'}, {'measure': 'Number of Participants Who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 78 days', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to approximately 36 days', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for new ways to treat Alzheimer's disease (AD). AD is a brain disease that causes a gradual decline in memory, thinking, and ability to carry out daily tasks. MK-1167 is a study medicine designed to treat symptoms of AD. Before giving a study medicine to people with a health condition, researchers first do studies in healthy people to find a safe dose of the study medicine.\n\nThe goals of the trial are to learn:\n\n* What happens to different forms of MK-1167 in a healthy person's body over time\n* About the safety of MK-1167 and if people tolerate it"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is in good health\n* Has a body mass index (BMI) ≥18 and ≤ 32 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases\n* Is a smoker and/or has used nicotine or nicotine-containing products within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT07334860', 'briefTitle': 'A Clinical Trial to Compare Forms of MK-1167 in Healthy People (MK-1167-011)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Two-Period, Open-label, Fixed-Sequence Study to Evaluate the Single-Dose Pharmacokinetics of Two Formulations of MK-1167 in Healthy Participants', 'orgStudyIdInfo': {'id': '1167-011'}, 'secondaryIdInfos': [{'id': 'MK-1167-011', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: MK-1167 Form 2', 'description': 'Participants receive MK-1167 Form 2 orally.', 'interventionNames': ['Drug: MK-1167']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: MK-1167 Form 1', 'description': 'Participants receive MK-1167 Form 1 orally.', 'interventionNames': ['Drug: MK-1167']}], 'interventions': [{'name': 'MK-1167', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Arm 1: MK-1167 Form 2', 'Arm 2: MK-1167 Form 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'QPS-MRA, LLC ( Site 0001)', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}