Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-01 @ 11:51 PM
Study NCT ID:
NCT07219550
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-10-20', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-1084 in plasma.'}, {'measure': 'Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-1084 in plasma.'}, {'measure': 'Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of MK-1084', 'timeFrame': 'Up to approximately 24 hours post-dose', 'description': 'Blood samples will be collected to determine the AUC0-24 of MK-1084 in plasma.'}, {'measure': 'Maximum Observed Drug Concentration (Cmax) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the Cmax of MK-1084 in plasma.'}, {'measure': 'Time to Maximum Observed Drug Concentration (Tmax) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the Tmax of MK-1084 in plasma.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-1084 in plasma.'}, {'measure': 'Apparent Clearance (CL/F) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the CL/F of MK-1084 in plasma.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084', 'timeFrame': 'At designated timepoints up to approximately 7 days post-dose', 'description': 'Blood samples will be collected to determine the Vz/F of MK-1084 in plasma.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 14 days', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Due to an AE', 'timeFrame': 'Up to approximately 14 days', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Hepatic Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn what happens to MK-1084 levels in a person's body over time. Researchers will measure what happens to MK-1084 levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The main inclusion criteria include but are not limited to:\n\nAll participants:\n\n* Has a body mass index (BMI) between 18.0 and 42.0 kg/m\\^2\n\nParticipants with hepatic impairment (HI):\n\n* Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis\n\nHealthy volunteers:\n\n* Is medically healthy with no clinically significant medical history\n\nThe main exclusion criteria include but are not limited to:\n\nAll participants:\n\n* Has a history of gastrointestinal disease which may affect food and drug absorption\n* Has a history of cancer (malignancy)\n* Has a positive result for human immunodeficiency virus (HIV)\n* Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing\n\nParticipants with HI:\n\n* Has had severe complications of liver disease within the preceding 3 months of screening\n* Has a history of recent (within 3 months prior to screening) variceal bleeds\n* Has evidence of hepatorenal syndrome\n* Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \\< 3 months\n* Has a history of liver or other solid organ transplantation\n* Has an active infection requiring systemic therapy\n* Requires paracentesis more often than 2 times per month\n* Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting\n* Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing\n* Is using HIV protease inhibitors\n* Is positive for Hepatitis B surface antigen (HBsAg)\n* Is positive for HCV\n\nHealthy volunteers:\n\n* Has positive results for HBsAg or HCV'}, 'identificationModule': {'nctId': 'NCT07219550', 'briefTitle': 'A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084', 'orgStudyIdInfo': {'id': '1084-017'}, 'secondaryIdInfos': [{'id': 'MK-1084-017', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-1084', 'description': 'All participants will receive a single oral dose of MK-1084 on Day 1.', 'interventionNames': ['Drug: MK-1084']}], 'interventions': [{'name': 'MK-1084', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['MK-1084']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '210-253-3426'}], 'facility': 'Arizona Clinical Trials ( Site 0003)', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '407-240-7878'}], 'facility': 'Orlando Clinical Research Center ( Site 0001)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '480-470-4000'}], 'facility': 'The Texas Liver Institute ( Site 0002)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], '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'}}}}