Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-08 @ 8:32 AM
Study NCT ID:
NCT06575933
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2024-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-inf of midazolam.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of midazolam.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-24hr of midazolam.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Cmax of midazolam.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Tmax of midazolam.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the t1/2 of midazolam.'}, {'measure': 'Apparent Clearance (CL/F) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the CL/F of midazolam.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Vz/F of midazolam.'}, {'measure': 'AUC0-Inf of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-inf of digoxin.'}, {'measure': 'AUC0-Last of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of digoxin.'}, {'measure': 'AUC0-24hr of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-24hr of digoxin.'}, {'measure': 'Cmax of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the Cmax of digoxin.'}, {'measure': 'Tmax of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the Tmax of digoxin.'}, {'measure': 't1/2 of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the t1/2 of digoxin.'}, {'measure': 'CL/F of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the CL/F of digoxin.'}, {'measure': 'Vz/F of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Blood samples will be collected to determine the Vz/F of digoxin.'}], 'secondaryOutcomes': [{'measure': 'AUC0-24hr of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-24hr of MK-1084.'}, {'measure': 'AUC0-Last of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-1084.'}, {'measure': 'Cmax of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Cmax of MK-1084.'}, {'measure': 'C24 of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Cmax of MK-1084.'}, {'measure': 'Tmax of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Tmax of MK-1084.'}, {'measure': 't1/2 of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-1084.'}, {'measure': 'Cmax Accumulation Ratio of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the Cmax accumulation ratio of MK-1084. The accumulation ratio is the ratio of Predose Cmax to the 24 hour Cmax'}, {'measure': 'AUC0-24 Accumulation Ratio of MK-1084', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the AUC0-24 accumulation ratio of MK-1084. The accumulation ratio is the ratio of Predose AUC0-24 to the 24 hour AUC0-24.'}, {'measure': 'Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Urine samples will be collected to determine the Aet1-t2 of digoxin.'}, {'measure': 'Total Amount of Drug Excreted in Urine (Ae) of Digoxin', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Urine samples will be collected to determine the Ae of digoxin.'}, {'measure': 'Fraction of Unchanged Digoxin in Urine (Fe)', 'timeFrame': 'Predose and at designated timepoints up to 120 hours postdose', 'description': 'Urine samples will be collected to determine the Fe of digoxin.'}, {'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 Due to an 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 discontinue study due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called MK-1084. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without MK-1084."}, '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* Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)\n* Has a body mass index (BMI) ≥18 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 medical history that may confound the results of the study or poses an additional risk to the participant in the study\n* Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds'}, 'identificationModule': {'nctId': 'NCT06575933', 'briefTitle': 'A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Evaluate the Effect of Single and Multiple Doses of MK-1084 on the Single-Dose Pharmacokinetics of Midazolam and Digoxin in Healthy Participants', 'orgStudyIdInfo': {'id': '1084-009'}, 'secondaryIdInfos': [{'id': 'CA43815', 'type': 'OTHER', 'domain': 'Celerion Protocol Number'}, {'id': 'MK-1084-009', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1: Midazolam and Digoxin', 'description': 'Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1.', 'interventionNames': ['Drug: Midazolam', 'Drug: Digoxin']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2: MK-1084, Midazolam, and Digoxin', 'description': 'A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first MK-1084 dosing in Period 2. Participants will receive MK-1084 once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11.', 'interventionNames': ['Drug: MK-1084', 'Drug: Midazolam', 'Drug: Digoxin']}], 'interventions': [{'name': 'MK-1084', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Period 2: MK-1084, Midazolam, and Digoxin']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Period 1: Midazolam and Digoxin', 'Period 2: MK-1084, Midazolam, and Digoxin']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Period 1: Midazolam and Digoxin', 'Period 2: MK-1084, Midazolam, and Digoxin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion ( Site 0001)', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], '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'}}}}