Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT07025551
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', '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-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527.'}, {'measure': 'Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527.'}, {'measure': 'Maximum Observed Concentration (Cmax) of MK-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527.'}, {'measure': 'Time to Maximum Concentration (Tmax) of MK-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527.'}, {'measure': 'Apparent Clearance (CL/F) of MK-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527', 'timeFrame': 'Predose and at designated timepoints up to 168 hours post dose', 'description': 'Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 29 days', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Number of Participants Who Discontinue Study Due to an AE', 'timeFrame': 'Up to approximately 29 days', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs)', 'timeFrame': 'Predose and at designated timepoints up to 672 hours post dose', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-8527-TP.'}, {'measure': 'Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs', 'timeFrame': 'At designated timepoints pre dose and up to approximately 672 hours post dose', 'description': 'Blood samples will be collected to determine the AUC0-672 of MK-8527-TP.'}, {'measure': 'Cmax of MK-8527-TP in PBMCs', 'timeFrame': 'Predose and at designated timepoints up to 672 hours post dose', 'description': 'Blood samples will be collected to determine the Cmax of MK-8527-TP.'}, {'measure': 'Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs', 'timeFrame': 'Predose and at designated timepoints up to 672 hours post dose', 'description': 'Blood samples will be collected to determine the C672 of MK-8527-TP.'}, {'measure': 'Tmax of MK-8527-TP in PBMCs', 'timeFrame': 'Predose and at designated timepoints up to 672 hours post dose', 'description': 'Blood samples will be collected to determine the Tmax of MK-8527-TP.'}, {'measure': 'T1/2 of MK-8527-TP in PBMCs', 'timeFrame': 'Predose and at designated timepoints up to 672 hours post dose', 'description': 'Blood samples will be collected to determine the Tmax of MK-8527-TP.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Impairment', 'Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \\[PK\\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\nAll participants:\n\n* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing\n* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\\^2\n\nParticipants with Mild HI (Group 1) and Moderate HI (Group 2):\n\n* Has mild or moderate hepatic impairment\n* Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology\n* Is generally in good health with the exception of HI\n\nHealthy Control Participants (Group 3):\n\n\\- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\nAll participants:\n\n* Has a history of cancer (malignancy)\n* Has positive results 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 Mild HI (Group 1) and Moderate HI (Group 2):\n\n* With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease\n* Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)\n* Is positive for Hepatitis C Virus (HCV)'}, 'identificationModule': {'nctId': 'NCT07025551', 'briefTitle': 'A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and Moderate Hepatic Impairment', 'orgStudyIdInfo': {'id': '8527-015'}, 'secondaryIdInfos': [{'id': 'MK-8527-015', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment (Group 1)', 'description': 'All participants will receive a single dose of MK-8527 on Day 1.', 'interventionNames': ['Drug: MK-8527']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment (Group 2)', 'description': 'All participants will receive a single dose of MK-8527 on Day 1.', 'interventionNames': ['Drug: MK-8527']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy (Group 3)', 'description': 'All participants will receive a single dose of MK-8527 on Day 1.', 'interventionNames': ['Drug: MK-8527']}], 'interventions': [{'name': 'MK-8527', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Healthy (Group 3)', 'Mild Hepatic Impairment (Group 1)', 'Moderate Hepatic Impairment (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '480-470-4000'}], 'facility': 'Arizona Clinical Trials ( Site 0001)', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}], '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'}}}}