Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06772805
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2025-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721068', 'term': 'ARQ531'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.'}], 'secondaryOutcomes': [{'measure': 'Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma.'}, {'measure': 'Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.'}, {'measure': 'Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.'}, {'measure': 'Maximum Observed Concentration (Cmax) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.'}, {'measure': 'Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib', 'timeFrame': 'Predose and at designated timepoints (up to approximately 2 weeks postdose)', 'description': 'Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.'}, {'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 30 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants Who Discontinue the Study Intervention Due to an AE', 'timeFrame': 'Up to approximately 14 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.'}]}, '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 the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed before randomization\n* Has a body mass index (BMI) 18 to 32 kg/m\\^2 (inclusive)\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Has a history of cancer (malignancy)'}, 'identificationModule': {'nctId': 'NCT06772805', 'briefTitle': 'A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Evaluate the Effect of Food on the Pharmacokinetics of the Nemtabrutinib Final Market Formulation 1 (FMF1) in Healthy Male Participants', 'orgStudyIdInfo': {'id': '1026-016'}, 'secondaryIdInfos': [{'id': 'MK-1026-016', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nemtabrutinib Treatment A', 'description': 'Participants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast)', 'interventionNames': ['Drug: Nemtabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Nemtabrutinib Treatment B', 'description': 'Participants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal)', 'interventionNames': ['Drug: Nemtabrutinib']}], 'interventions': [{'name': 'Nemtabrutinib', 'type': 'DRUG', 'otherNames': ['MK-1026', 'ARQ-531'], 'description': 'Oral Tablet', 'armGroupLabels': ['Nemtabrutinib Treatment A', 'Nemtabrutinib Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Labcorp Clinical Research Unit Inc. (Site 0001)', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], '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'}}}}