Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:58 AM
Study NCT ID:
NCT07435194
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-24', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hours (hrs) postdose', 'description': 'Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.'}, {'measure': 'Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the Cmax of Midazolam.'}], 'secondaryOutcomes': [{'measure': 'Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the AUC0-last of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 24 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the AUC0-24 of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the Tmax of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the t1/2 of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the CL/F of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828', 'timeFrame': '24 hours postdose', 'description': 'Blood samples will be collected at multiple time points to determine the C24 of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828', 'timeFrame': 'Predose and at designated timepoints up to approximately 288 hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the Vz/F of MK-2828.'}, {'measure': 'Part 1 (Itraconazole): Number of Participants Experiencing an Adverse Event (AE)', 'timeFrame': 'Up to approximately 28 days', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.'}, {'measure': 'Part 1 (Itraconazole): Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 23 days', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.'}, {'measure': 'Part 2 (Midazolam): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the AUC0-last of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the AUC0-24 of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Time to Maximum Plasma Concentration (Tmax) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the Tmax of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Apparent Terminal Half-life (t1/2) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the t1/2 of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Apparent Clearance (CL/F) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the CL/F of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam', 'timeFrame': '24 hours postdose', 'description': 'Blood samples will be collected at multiple time points to determine the C24 of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to approximately 24hrs postdose', 'description': 'Blood samples will be collected at multiple time points to determine the Vz/F of Midazolam.'}, {'measure': 'Part 2 (Midazolam): Number of Participants Experiencing an adverse event (AE)', 'timeFrame': 'Up to approximately 23 days', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.'}, {'measure': 'Part 2 (Midazolam): Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 9 days', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued 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 main goals of this study are:\n\n* To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole\n* To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828\n\nResearchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose."}, '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\\- Participant is in good health\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of cancer (malignancy)\n* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases'}, 'identificationModule': {'nctId': 'NCT07435194', 'briefTitle': 'A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Two-Part Clinical Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-2828 (Part 1) and Multiple Doses of MK-2828 on the Single-Dose PK of Midazolam (Part 2) in Healthy Participants', 'orgStudyIdInfo': {'id': '2828-007'}, 'secondaryIdInfos': [{'id': 'MK-2828-007', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Itraconazole', 'description': 'Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.', 'interventionNames': ['Drug: MK-2828', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Midazolam', 'description': 'Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.', 'interventionNames': ['Drug: MK-2828', 'Drug: Midazolam']}], 'interventions': [{'name': 'MK-2828', 'type': 'DRUG', 'description': 'Administered orally as capsule', 'armGroupLabels': ['Part 1: Itraconazole', 'Part 2: Midazolam']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Administered orally as syrup', 'armGroupLabels': ['Part 1: Itraconazole']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Administered orally as syrup', 'armGroupLabels': ['Part 2: Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '608-210-5454'}], 'facility': 'Fortea CRU Madison ( Site 0001)', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@merck.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'}}}}