Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-19 @ 2:52 PM
Study NCT ID:
NCT06586606
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D017964', 'term': 'Itraconazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-1708.'}, {'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 11 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 who experience an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Due to an AE', 'timeFrame': 'Up to approximately 11 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 who discontinue study due to an AE will be reported.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-1708.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the Cmax of MK-1708.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the Tmax of MK-1708.'}, {'measure': 'Plasma Concentration at 24 Hours (C24) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the C24 of MK-1708.'}, {'measure': 'Apparent Clearance (CL/F) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the CL/F of MK-1708.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the Vz/F of MK-1708.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-1708', 'timeFrame': 'Predose and at designated timepoints up to approximately 2 weeks postdose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-1708.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Is in good health before randomization\n* Has a body mass index (BMI) ≥18.5 and ≤32 kg/m\\^2, inclusive\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 (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Has a history of cancer'}, 'identificationModule': {'nctId': 'NCT06586606', 'briefTitle': 'A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Two-Period Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single Dose PK of MK-1708 in Healthy Participants', 'orgStudyIdInfo': {'id': '1708-003'}, 'secondaryIdInfos': [{'id': 'MK-1708-003', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1: MK-1708', 'description': 'Participants will receive a single oral dose of MK-1708 on Day 1.', 'interventionNames': ['Drug: MK-1708']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2: MK-1708 and Itraconazole', 'description': 'A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.', 'interventionNames': ['Drug: MK-1708', 'Drug: Itraconazole']}], 'interventions': [{'name': 'MK-1708', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Period 1: MK-1708', 'Period 2: MK-1708 and Itraconazole']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Period 2: MK-1708 and Itraconazole']}]}, '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': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}