Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
Study NCT ID:
NCT06596668
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2024-09-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730033', 'term': 'bomedemstat'}, {'id': 'D002220', 'term': 'Carbamazepine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 'AUC0-inf for bomedemstat in plasma will be determined'}], 'secondaryOutcomes': [{'measure': 'Number of participants who experience one or more adverse events (AEs)', 'timeFrame': 'Up to approximately 66 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.'}, {'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.'}, {'measure': 'Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 'AUC0-last for bomedemstat in plasma will be determined'}, {'measure': 'Area under the concentration versus time curve from 0 to 24 hours after dosing (AUC0-24) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'AUC0-24 for bomedemstat in plasma will be determined'}, {'measure': 'Maximum observed concentration (Cmax) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 'Cmax for bomedemstat in plasma will be determined'}, {'measure': 'Maximum observed concentration 24 hours after dosing (C24) bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 24 hours postdose', 'description': 'Cmax for bomedemstat in plasma will be determined'}, {'measure': 'Time to maximum concentration (Tmax) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 'Tmax for bomedemstat in plasma will be determined'}, {'measure': 'Apparent terminal half-life (t1/2) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 't1/2 for bomedemstat in plasma will be determined'}, {'measure': 'Apparent clearance (CL/F) of bomedemstat', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 'CL/F for bomedemstat in plasma will be determined'}, {'measure': 'Apparent volume of distribution during terminal phase (Vz/F) of bomedemstat in plasma', 'timeFrame': 'Predose and at designated timepoints up to 168 hours postdose', 'description': 'Vz/F for bomedemstat in plasma will be determined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "Researchers have designed a study medicine called bomedemstat (MK-3543) as a new way to treat certain rare blood diseases.\n\nThe purpose of this study is to learn what happens to bomedemstat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to bomedemstat in the body when it is given alone and after multiple doses of another medicine called carbamazepine (CBZ)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months before entering the study.\n* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\\^2\n* Medically healthy with no clinically significant medical history\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History or presence of any of the following:\n\n * Seizures\n * Negative reactions in the blood system to any drugs\n * Depression, unusual changes in mood or behavior or suicidal thoughts or behavior\n* History of cancer\n* Regular user of cannabis products within 6 months before entering the study.\n* Unable to stop using or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before entering the study.'}, 'identificationModule': {'nctId': 'NCT06596668', 'briefTitle': 'Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Phase 1 Study to Characterize the Effects of a Strong Cytochrome P450 3A4 Inducer on the Pharmacokinetics of Bomedemstat in Healthy Adult Participants', 'orgStudyIdInfo': {'id': '3543-020'}, 'secondaryIdInfos': [{'id': 'MK-3543-020', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bomedemstat + Carbamazepine', 'description': 'A single dose of bomedemstat will be administered On Day 1 of Period 1. There will be a washout of 7 days between bomedemstat dosing in Period 1 and the first carbamazepine (CBZ) dose in Period 2. In Period 2, CBZ will be administered twice daily (BID) for 17 consecutive days, with a single dose of bomedemstat coadministered with the morning dose on Day 14.', 'interventionNames': ['Drug: bomedemstat', 'Drug: carbamazepine']}], 'interventions': [{'name': 'bomedemstat', 'type': 'DRUG', 'otherNames': ['MK-3543'], 'description': 'Oral tablet', 'armGroupLabels': ['Bomedemstat + Carbamazepine']}, {'name': 'carbamazepine', 'type': 'DRUG', 'description': 'Oral extended-release capsule', 'armGroupLabels': ['Bomedemstat + Carbamazepine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion, Inc. ( Site 0001)', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], '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'}}}}