Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-09 @ 7:34 AM
Study NCT ID:
NCT06818968
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2025-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004110', 'term': 'Diltiazem'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 8 weeks)', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-6916.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 24 hours)', 'description': 'Blood samples will be collected to determine the AUC0-24 of MK-6916.'}, {'measure': 'Plasma Concentration at 24 Hours (C24) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 24 hours)', 'description': 'Blood samples will be collected to determine the C24 of MK-6916.'}, {'measure': 'Plasma Concentration at 12 Hours (C12) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 12 hours)', 'description': 'Blood samples will be collected to determine the C12 of MK-6916.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 8 weeks)', 'description': 'Blood samples will be collected to determine the Cmax of MK-6916.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 8 weeks)', 'description': 'Blood samples will be collected to determine the Tmax of MK-6916.'}, {'measure': 'Apparent Clearance (CL/F) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 8 weeks)', 'description': 'Blood samples will be collected to determine the CL/F of MK-6916.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 8 weeks)', 'description': 'Blood samples will be collected to determine the Vz/F of MK-6916.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-6916', 'timeFrame': 'Predose and at designated time points (up to 8 weeks)', 'description': 'Blood samples will be collected to determine the t1/2 of MK-6916.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 8 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 8 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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': "The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 in the body when it is given with or without another medicine called diltiazem."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Has a body-mass index (BMI) 18 to 32 kg/m\\^2\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases\n* Has a history of cancer (malignancy)\n* Has a history of cardiac arrhythmia or recurrent unexplained syncopal events\n* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome\n* Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus'}, 'identificationModule': {'nctId': 'NCT06818968', 'briefTitle': 'A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 2-period, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-dose Pharmacokinetics of MK-6916 in Healthy Participants', 'orgStudyIdInfo': {'id': '6916-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-6916 + Diltiazem', 'description': 'Participants will receive MK-6916 and diltiazem orally.', 'interventionNames': ['Drug: MK-6916', 'Drug: Diltiazem']}], 'interventions': [{'name': 'MK-6916', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['MK-6916 + Diltiazem']}, {'name': 'Diltiazem', 'type': 'DRUG', 'otherNames': ['MK-M793'], 'description': 'Oral administration', 'armGroupLabels': ['MK-6916 + Diltiazem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Fortrea CRU, Madison ( Site 0001)', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}}}}