Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-04-08 @ 5:47 AM
Study NCT ID:
NCT06719557
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Itraconazole and Phenytoin on MK-1084 in Healthy Adults (MK-1084-008)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D010672', 'term': 'Phenytoin'}], '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': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the AUC0-Inf of MK-1084.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-1084.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 24 hours post dose', 'description': 'Blood samples will be collected to determine the AUC0-24 of MK-1084.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the Cmax of MK-1084.'}, {'measure': 'Plasma Concentration at 24 Hours (C24) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 24 hours post dose', 'description': 'Blood samples will be collected to determine the C24 of MK-1084.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the Tmax of MK-1084.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-1084.'}, {'measure': 'Apparent Clearance (CL/F) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the CL/F of MK-1084.'}, {'measure': 'Apparent volume of distribution during terminal phase (Vz/F) of MK-1084', 'timeFrame': 'Pre-dose and at designated time points up to 72 hours post dose', 'description': 'Blood samples will be collected to determine the Vz/F of MK-1084.'}, {'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 41 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. 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 25 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. 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': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to learn what happens to MK-1084 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of MK-1084 when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n\\- Has body mass index (BMI) ≥18 kg/m\\^2 and ≤32 kg/m\\^2\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of cancer (malignancy)\n* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)\n\nPart 1 Only:\n\n\\- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)\n\nPat 2 Only:\n\n\\- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions'}, 'identificationModule': {'nctId': 'NCT06719557', 'briefTitle': 'A Study of the Effect of Itraconazole and Phenytoin on MK-1084 in Healthy Adults (MK-1084-008)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Two-Part Study to Evaluate the Effects of Multiple Doses of Itraconazole and Multiple Doses of Phenytoin on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants', 'orgStudyIdInfo': {'id': '1084-008'}, 'secondaryIdInfos': [{'id': 'MK-1084-008', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'CA43207', 'type': 'OTHER', 'domain': 'Celerion'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: MK-1084 + Itraconazole', 'description': 'Part 1: In Period 1 participants receive a single dose of MK-1084 on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of MK-1084 administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.', 'interventionNames': ['Drug: MK-1084', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: MK-1084 + Phenytoin', 'description': 'Part 2: In Period 1 participants receive a single dose of MK-1084 on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of MK-1084 co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.', 'interventionNames': ['Drug: MK-1084', 'Drug: Phenytoin']}], 'interventions': [{'name': 'MK-1084', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Part 1: MK-1084 + Itraconazole', 'Part 2: MK-1084 + Phenytoin']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Oral solution', 'armGroupLabels': ['Part 1: MK-1084 + Itraconazole']}, {'name': 'Phenytoin', 'type': 'DRUG', 'description': 'Oral capsule (extended)', 'armGroupLabels': ['Part 2: MK-1084 + Phenytoin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion (Site 0001)', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], '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'}}}}