Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-08 @ 6:36 PM
Study NCT ID:
NCT06609161
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2024-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the AUC0-Inf of tedizolid.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the AUC0-Last of tedizolid.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Tedizolid', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the Cmax of tedizolid.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 2 weeks postdose', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.'}, {'measure': 'Number of Participants Who Discontinue Study Drug Due to an AE', 'timeFrame': 'Up to approximately 2 weeks postdose', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Tedizolid', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the Tmax of tedizolid.'}, {'measure': 'Apparent Terminal Half-Life (t1/2) of Tedizolid', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the t1/2 of tedizolid.'}, {'measure': 'Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the Vz/F of tedizolid.'}, {'measure': 'Apparent Clearance (CL/F) of Tedizolid', 'timeFrame': 'At designated time points (up to 3 days postdose)', 'description': 'Blood samples will be collected to determine the CL/F of tedizolid.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\\^2\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia\n* Has a history of clostridium difficile-associated diarrhea'}, 'identificationModule': {'nctId': 'NCT06609161', 'briefTitle': 'A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies', 'orgStudyIdInfo': {'id': '1986-044'}, 'secondaryIdInfos': [{'id': 'MK-1986-044', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tedizolid Phosphate Oral Formulation 1 (Reference)', 'description': 'Participants will receive oral Formulation 1 (Reference).', 'interventionNames': ['Drug: Tedizolid Phosphate Oral Formulation 1 (Reference)']}, {'type': 'EXPERIMENTAL', 'label': 'Tedizolid Phosphate Oral Formulation 2 (Test)', 'description': 'Participants will receive oral Formulation 2 (Test).', 'interventionNames': ['Drug: Tedizolid Phosphate Oral Formulation 2 (Test)']}], 'interventions': [{'name': 'Tedizolid Phosphate Oral Formulation 1 (Reference)', 'type': 'DRUG', 'description': 'Formulation 1 (FM1) powder for oral suspension.', 'armGroupLabels': ['Tedizolid Phosphate Oral Formulation 1 (Reference)']}, {'name': 'Tedizolid Phosphate Oral Formulation 2 (Test)', 'type': 'DRUG', 'description': 'Formulation 2 (FM2) powder for oral suspension.', 'armGroupLabels': ['Tedizolid Phosphate Oral Formulation 2 (Test)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion (Site 0001)', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], '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'}}}}