Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-16 @ 2:44 AM
Study NCT ID:
NCT06777602
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)
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': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount Excreted in Urine (Aeu)', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Amount of \\[14C\\]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.'}, {'measure': 'Cumulative Aeu', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Cumulative amount of \\[14C\\] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval'}, {'measure': 'Percentage Excreted in Urine (feu)', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Percentage of \\[14C\\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.'}, {'measure': 'Cumulative feu', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Cumulative percentage of \\[14C\\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.'}, {'measure': 'Amount Excreted in Feces (Aef)', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Amount of \\[14C\\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.'}, {'measure': 'Cumulative Aef', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Cumulative amount of \\[14C\\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.'}, {'measure': 'Cumulative Fef', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Cumulative percentage of \\[14C\\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.'}, {'measure': 'AUC0-t', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of \\[14C\\]MK-5475.'}, {'measure': 'AUC0-infinity', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of \\[14C\\]MK-5475.'}, {'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Cmax is the measure of the maximum amount of \\[14C\\]MK-5475 in the plasma after the dose is given.'}, {'measure': 'Half-life t1/2', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'T1/2 is the time required for \\[14C\\]MK-5475 concentration in the plasma to decrease by 50%.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax),', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Tmax is a measure of the time to reach the maximum concentration in the plasma after the \\[14C\\]MK-5475 dose.'}, {'measure': 'Apparent Total Clearance (CL; MK-5475 only)', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'CL is defined as apparent total clearance of \\[14C\\]MK-5475 from plasma after IV administration'}, {'measure': 'Apparent Volume of Distribution (Vz; MK-5475 only)', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'Vz is defined as apparent volume of distribution of \\[14C\\]MK-5475 during terminal phase after IV administration.'}, {'measure': 'AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio', 'timeFrame': 'At designated time points (Up to ~ 23 days)', 'description': 'AUC time zero to infinity (0-∞) of \\[14C\\]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to ~ 30 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. 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 ~ 30 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. The number of participants who discontinue study due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40534306', 'type': 'RESULT', 'citation': 'Menzel K, Liang Y, Chen B, Li D, Cislak D, Bajwa EK. An Intravenous Study with the Radiolabeled sGC Stimulator Frespaciguat to Assess PK, Metabolism, and Mass Balance. J Clin Pharmacol. 2025 Nov;65(11):1561-1567. doi: 10.1002/jcph.70066. Epub 2025 Jun 19.'}], 'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy adult male participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is in good health.\n* Body mass index (BMI) \\>18 and ≤32 kg/m2, inclusive.\n\nExclusion Criteria:\n\n* Has 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 significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.\n* Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).\n* Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.\n* Has participated in more than 3 radiolabeled drug studies in the last 12 months.'}, 'identificationModule': {'nctId': 'NCT06777602', 'briefTitle': 'A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label Phase 1 IV Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]MK-5475 in Healthy Participants', 'orgStudyIdInfo': {'id': '5475-011'}, 'secondaryIdInfos': [{'id': 'MK-5475-011', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C] MK-5475', 'description': '\\[14C\\] MK-5475 is administered as single IV bolus dose of 100μg on Day 1.', 'interventionNames': ['Drug: [14C] MK-5475']}], 'interventions': [{'name': '[14C] MK-5475', 'type': 'DRUG', 'description': '\\[14C\\] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.', 'armGroupLabels': ['[14C] MK-5475']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Labcorp Clinical Research Unit Inc. (Site 0001)', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}}}}