Nctid:
NCT06615869
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000656703", "term"=>"Molnupiravir"}], "ancestors"=>[{"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M254020", "name"=>"Molnupiravir", "asFound"=>"TKR", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>64}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-01-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2023-03-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-02-27", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"AUC0-inf of NHC in plasma will be determined."}, {"measure"=>"Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"AUC0-last of NHC in plasma will be determined."}, {"measure"=>"Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 12 hours postdose", "description"=>"AUC0-12 of NHC in plasma will be determined."}, {"measure"=>"Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Cmax of NHC in plasma will be determined."}, {"measure"=>"Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Tmax of NHC in plasma will be determined."}, {"measure"=>"Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"t1/2 of NHC in plasma will be determined."}, {"measure"=>"Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"CL/F of NHC in plasma will be determined."}, {"measure"=>"Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Vz/F of NHC in plasma will be determined."}], "secondaryOutcomes"=>[{"measure"=>"AUC0-inf of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"AUC0-inf of NHC in plasma will be determined."}, {"measure"=>"AUC0-last of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"AUC0-last of NHC in plasma will be determined."}, {"measure"=>"AUC0-12 of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 12 hours postdose", "description"=>"AUC0-12 of NHC in plasma will be determined."}, {"measure"=>"Cmax of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Cmax of NHC in plasma will be determined."}, {"measure"=>"Tmax of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Tmax of NHC in plasma will be determined."}, {"measure"=>"t1/2 of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"t1/2 of NHC in plasma will be determined."}, {"measure"=>"CL/F of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"CL/F of NHC in plasma will be determined."}, {"measure"=>"Vz/F of NHC in plasma: Treatment B versus Treatment C", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Vz/F of NHC in plasma will be determined."}, {"measure"=>"AUC0-inf of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"AUC0-inf of NHC in plasma will be determined."}, {"measure"=>"AUC0-last of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"AUC0-last of NHC in plasma will be determined."}, {"measure"=>"AUC0-12 of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 12 hours postdose", "description"=>"AUC0-12 of NHC in plasma will be determined."}, {"measure"=>"Cmax of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Cmax of NHC in plasma will be determined."}, {"measure"=>"Tmax of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Tmax of NHC in plasma will be determined."}, {"measure"=>"t1/2 of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"t1/2 of NHC in plasma will be determined."}, {"measure"=>"CL/F of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"CL/F of NHC in plasma will be determined."}, {"measure"=>"Vz/F of NHC in plasma: Treatment D versus Treatment A", "timeFrame"=>"Pre-dose, and at designated timepoints up to 72 hours postdose", "description"=>"Vz/F of NHC in plasma will be determined."}, {"measure"=>"Number of participants who experience one or more adverse events (AEs)", "timeFrame"=>"Up to ~ 38 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."}, {"measure"=>"Number of participants who discontinue study intervention due to an AE", "timeFrame"=>"Up to ~ 38 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."}]}, "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 forms of molnupiravir (MOV) medications in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare the amount of MOV in the healthy person's body over time when different forms of medications are given."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n- Has body mass index (BMI) ≥18 kg/m\\^2 and ≤32 kg/m\\^2.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* 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* 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* Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV).\n* History of a major surgery."}, "identificationModule"=>{"nctId"=>"NCT06615869", "briefTitle"=>"A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Merck Sharp & Dohme LLC"}, "officialTitle"=>"A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants", "orgStudyIdInfo"=>{"id"=>"4482-011"}, "secondaryIdInfos"=>[{"id"=>"MK-4482-011", "type"=>"OTHER", "domain"=>"MSD"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Molnupiravir Treatment A", "description"=>"Participants receive molnupiravir reference capsule.", "interventionNames"=>["Drug: Molnupiravir"]}, {"type"=>"EXPERIMENTAL", "label"=>"Molnupiravir Treatment B", "description"=>"Participants receive molnupiravir Formulation 1.", "interventionNames"=>["Drug: Molnupiravir"]}, {"type"=>"EXPERIMENTAL", "label"=>"Molnupiravir Treatment C", "description"=>"Participants receive molnupiravir Formulation 1 after a high-fat meal.", "interventionNames"=>["Drug: Molnupiravir"]}, {"type"=>"EXPERIMENTAL", "label"=>"Molnupiravir Treatment D", "description"=>"Participants receive molnupiravir Formulation 2.", "interventionNames"=>["Drug: Molnupiravir"]}], "interventions"=>[{"name"=>"Molnupiravir", "type"=>"DRUG", "otherNames"=>["MK-4482", "MOV", "LAGEVRIO", "EIDD-2801"], "description"=>"Oral Administration.", "armGroupLabels"=>["Molnupiravir Treatment A", "Molnupiravir Treatment B", "Molnupiravir Treatment C", "Molnupiravir Treatment D"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33143", "city"=>"South Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"QPS-MRA, LLC-Early Phase (Site 0002)", "geoPoint"=>{"lat"=>25.7076, "lon"=>-80.29338}}], "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"}}}}
