{ "FullStudy":{ "Rank":218200, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511432", "OrgStudyIdInfo":{ "OrgStudyId":"VX11-950-025" }, "Organization":{ "OrgFullName":"Vertex Pharmaceuticals Incorporated", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects", "OfficialTitle":"A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects" }, "StatusModule":{ "StatusVerifiedDate":"July 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 9, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 3, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 4, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Vertex Pharmaceuticals Incorporated", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Hepatitis C" ] }, "KeywordList":{ "Keyword":[ "Relative bioavailability", "telaprevir formulations" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"64", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Part A", "ArmGroupType":"Experimental", "ArmGroupDescription":"Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: telaprevir formulation A", "Drug: telaprevir Formulation B", "Drug: telaprevir Formulation C", "Drug: telaprevir Formulation D" ] } },{ "ArmGroupLabel":"Part B", "ArmGroupType":"Experimental", "ArmGroupDescription":"Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: telaprevir formulation A", "Drug: telaprevir Formulation B", "Drug: telaprevir Formulation C", "Drug: telaprevir Formulation D" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"telaprevir formulation A", "InterventionDescription":"A single 1125-mg dose administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part A", "Part B" ] } },{ "InterventionType":"Drug", "InterventionName":"telaprevir Formulation B", "InterventionDescription":"A single 1125-mg dose administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part A", "Part B" ] } },{ "InterventionType":"Drug", "InterventionName":"telaprevir Formulation C", "InterventionDescription":"A single 1125-mg dose administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part A", "Part B" ] } },{ "InterventionType":"Drug", "InterventionName":"telaprevir Formulation D", "InterventionDescription":"A single 1125-mg dose administered orally", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part A", "Part B" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)", "PrimaryOutcomeTimeFrame":"Up to 57 days" },{ "PrimaryOutcomeMeasure":"• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)", "PrimaryOutcomeTimeFrame":"Up to 57 Days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms", "SecondaryOutcomeTimeFrame":"Up to 57days" },{ "SecondaryOutcomeMeasure":"Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir", "SecondaryOutcomeTimeFrame":"Up to 57 Days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years\nNon-childbearing potential female subjects\nMale subjects and female partners must agree to use at least 2 methods of contraception\nSubjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit.\n\nExclusion Criteria:\n\nSubjects with a positive test result for hepatitis B, hepatitis C, or HIV\nSubjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption\nSubjects with a positive urine screen for drugs of abuse\nSubjects with a history of regular alcohol consumption\nSubjects treated with an investigational drug within 30 days\nFor Part A only: Subjects with 12-lead ECG QTcF >450 msec (males) or QTcF >470 msec (females) at the Screening Visit\nSubjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements\nSubjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug\nSubjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug\nSubjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug\nSubjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"55 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Texas", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75247", "LocationCountry":"United States" },{ "LocationFacility":"Wisconsin", "LocationCity":"Madison", "LocationState":"Wisconsin", "LocationZip":"53704", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006526", "ConditionMeshTerm":"Hepatitis C" },{ "ConditionMeshId":"D000019698", "ConditionMeshTerm":"Hepatitis C, Chronic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006505", "ConditionAncestorTerm":"Hepatitis" },{ "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000006525", "ConditionAncestorTerm":"Hepatitis, Viral, Human" },{ "ConditionAncestorId":"D000014777", "ConditionAncestorTerm":"Virus Diseases" },{ "ConditionAncestorId":"D000018178", "ConditionAncestorTerm":"Flaviviridae Infections" },{ "ConditionAncestorId":"D000012327", "ConditionAncestorTerm":"RNA Virus Infections" },{ "ConditionAncestorId":"D000006521", "ConditionAncestorTerm":"Hepatitis, Chronic" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8174", "ConditionBrowseLeafName":"Hepatitis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8175", "ConditionBrowseLeafName":"Hepatitis A", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8194", "ConditionBrowseLeafName":"Hepatitis C", "ConditionBrowseLeafAsFound":"Hepatitis C", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20197", "ConditionBrowseLeafName":"Hepatitis C, Chronic", "ConditionBrowseLeafAsFound":"Chronic Hepatitis C", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8190", "ConditionBrowseLeafName":"Hepatitis, Chronic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8193", "ConditionBrowseLeafName":"Hepatitis, Viral, Human", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16105", "ConditionBrowseLeafName":"Virus Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18907", "ConditionBrowseLeafName":"Flaviviridae Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13732", "ConditionBrowseLeafName":"RNA Virus Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC02", "ConditionBrowseBranchName":"Viral Diseases" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }