Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07431866
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-23', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the AUC0-inf of rosuvastatin.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the AUC0-inf of furosemide.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 1 month', '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 Treatment Due to an AE', 'timeFrame': 'Up to approximately 2 weeks', '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 in who discontinue study treatment due to an AE will be reported.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the AUC0-last of rosuvastatin.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the AUC0-last of furosemide.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 24 hours)', 'description': 'Blood samples will be collected to determine the AUC0-24 of rosuvastatin.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 24 hours)', 'description': 'Blood samples will be collected to determine the AUC0-24 of furosemide.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the Cmax of rosuvastatin.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the Cmax of furosemide.'}, {'measure': 'Time of the Maximum Plasma Concentration (Tmax) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the Tmax of rosuvastatin.'}, {'measure': 'Time of the Maximum Plasma Concentration (Tmax) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the Tmax of furosemide.'}, {'measure': 'Terminal Half-life (t1/2) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the t1/2 of rosuvastatin.'}, {'measure': 'Terminal Half-life (t1/2) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the t1/2 of furosemide.'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the CL/F of rosuvastatin.'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the CL/F of furosemide.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Rosuvastatin', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the Vz/F of rosuvastatin.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Furosemide', 'timeFrame': 'At designated time points (up to approximately 2 weeks)', 'description': 'Blood samples will be collected to determine the Vz/F of furosemide.'}]}, '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 other ways to treat people who have heart failure with preserved ejection fraction (HFpEF). HFpEF is a type of heart failure where the heart becomes stiff and does not relax properly. MK-2828 is a study medicine designed to treat HFpEF.\n\nThe main goal of the study is to learn if MK-2828 affects what happens to rosuvastatin or furosemide in the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is in good health\n* Has a body mass index (BMI) ≥18 and ≤32 kg/m\\^2\n\nExclusion Criteria:\n\nThe main 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)'}, 'identificationModule': {'nctId': 'NCT07431866', 'briefTitle': 'A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Two-Part Clinical Study to Evaluate the Effect of Multiple Doses of MK-2828 on Rosuvastatin (Part 1) and Furosemide (Part 2) in Healthy Participants', 'orgStudyIdInfo': {'id': '2828-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin + MK-2828', 'description': 'Participants receive rosuvastatin and MK-2828 orally.', 'interventionNames': ['Drug: Rosuvastatin', 'Drug: MK-2828']}, {'type': 'EXPERIMENTAL', 'label': 'Furosemide + MK-2828', 'description': 'Participants receive furosemide and MK-2828 orally.', 'interventionNames': ['Drug: Furosemide', 'Drug: MK-2828']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Rosuvastatin + MK-2828']}, {'name': 'Furosemide', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Furosemide + MK-2828']}, {'name': 'MK-2828', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Furosemide + MK-2828', 'Rosuvastatin + MK-2828']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '386-366-6414'}], 'facility': 'Fortrea Clinical Research Unit Inc ( Site 0001)', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], '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'}}}}