Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
Study NCT ID:
NCT06575595
Status:
COMPLETED
Last Update Posted:
2025-02-18
First Post:
2024-08-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve from Time 0 to Infinity (AUC0-inf): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the AUC0-inf of tulisokibart. AUC0-inf is defined as the area under concentration-time curve of tulisokibart from time zero to infinity.'}, {'measure': 'Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0- last): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the AUC0-last of tulisokibart. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of tulisokibart.'}, {'measure': 'Maximum Plasma Concentration (Cmax): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the Cmax of tulisokibart. Cmax is defined as the maximum concentration of tulisokibart reached.'}, {'measure': 'Time to Cmax (Tmax): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the Tmax of tulisokibart. Tmax is defined as the time to maximum concentration of tulisokibart reached.'}, {'measure': 'Clearance after Nonintravenous Administration (CL/F): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the CL/V of tulisokibart. CL/F is the rate at which the tulisokibart is completely removed from plasma.'}, {'measure': 'Volume of Distribution (V/F): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the V/F of tulisokibart. V/F is the volume of distribution of tulisokibart.'}, {'measure': 'Half Life (t1/2): Treatment A', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the t1/2 of tulisokibart. t1/2 is defined as the time required to divide plasma concentration of tulisokibart by half.'}], 'secondaryOutcomes': [{'measure': 'AUC0-inf: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the AUC0-inf of tulisokibart. AUC0-inf is defined as the area under concentration-time curve of tulisokibart from time zero to infinity.'}, {'measure': 'AUC0-last: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the AUC0-last of tulisokibart. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of tulisokibart.'}, {'measure': 'Cmax: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the Cmax of tulisokibart. Cmax is defined as the maximum concentration of tulisokibart reached.'}, {'measure': 'Tmax: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the Tmax of tulisokibart. Tmax is defined as the time to maximum concentration of tulisokibart reached.'}, {'measure': 'CL/V: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the CL/V of tulisokibart. CL/F is the rate at which the tulisokibart is completely removed from plasma.'}, {'measure': 'V/F: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the V/F of tulisokibart. V/F is the volume of distribution of tulisokibart.'}, {'measure': 't1/2: Treatment B vs Treatment C', 'timeFrame': 'Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99)', 'description': 'Blood will be collected at pre-specified time points to determine the t1/2 of tulisokibart. t1/2 is defined as the time required to divide plasma concentration of tulisokibart by half.'}]}, '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 primary objectives of the study are to characterize the pharmacokinetics (PK) of a single subcutaneous (SC) dose of tulisokibart (MK-7240) administered via autoinjector (AI) (Treatment A) and to characterize the PK of different concentrations of tulisokibart following SC administration of a single dose via vial/syringe (Treatments B and C). There is no formal hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is in good health\n* Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive\n* Has a weight between 50 and 100 kg, inclusive\n\nExclusion Criteria:\n\n* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years or has had diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) in which the possibility of malignancy cannot be reasonably excluded following additional clinical assessments\n* Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food\n* Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV); OR positive hepatitis B core antibody (HBcAb) with negative hepatitis B core antibody (HBsAb)\n* Has a history of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection\n* Has a history of or current active tuberculosis (TB) infection; history of latent TB that was not fully treated or a positive QuantiFERON-TB test at screening\n* Is a smoker and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening\n* Consumes greater than 3 servings of alcoholic beverages per day\n* Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months'}, 'identificationModule': {'nctId': 'NCT06575595', 'briefTitle': 'Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Pharmacokinetic Study of Tulisokibart Administered Subcutaneously Via Autoinjector or Syringe in Healthy Adult Participants', 'orgStudyIdInfo': {'id': '7240-010'}, 'secondaryIdInfos': [{'id': 'MK-7240-010', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Single dose delivered subcutaneously (SC) with an autoinjector', 'interventionNames': ['Biological: Tulisokibart']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Single dose of concentration A delivered SC with syringe and vial', 'interventionNames': ['Biological: Tulisokibart']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'Single dose of concentration B delivered SC with syringe and vial', 'interventionNames': ['Biological: Tulisokibart']}], 'interventions': [{'name': 'Tulisokibart', 'type': 'BIOLOGICAL', 'otherNames': ['MK-7240'], 'description': 'single dose via SC autoinjector (Treatment A) or concentration A or concentration B SC injection via syringe and vial (Treatments B and C)', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'QPS Missouri ( Site 0003)', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], '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'}}}}