{ "FullStudy":{ "Rank":217931, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514968", "OrgStudyIdInfo":{ "OrgStudyId":"NP27947" }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers", "OfficialTitle":"A Drug-Drug Interaction Study Between Danoprevir/Low-dose Ritonavir and Cyclosporine, a Potent Inhibitor of OATP, in Healthy Subjects" }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 1, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 2, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy Volunteer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"18", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"DNV/r+cyclosporine", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: cyclosporine", "Drug: danoprevir", "Drug: ritonavir" ] } },{ "ArmGroupLabel":"cyclosporine", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: cyclosporine" ] } },{ "ArmGroupLabel":"danoprevir+ritonavir", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: danoprevir", "Drug: ritonavir" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"cyclosporine", "InterventionDescription":"Single oral dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DNV/r+cyclosporine", "cyclosporine" ] } },{ "InterventionType":"Drug", "InterventionName":"danoprevir", "InterventionDescription":"Single oral dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DNV/r+cyclosporine", "danoprevir+ritonavir" ] } },{ "InterventionType":"Drug", "InterventionName":"ritonavir", "InterventionDescription":"Single oral dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DNV/r+cyclosporine", "danoprevir+ritonavir" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC)", "PrimaryOutcomeTimeFrame":"16 time points up to 96 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine", "SecondaryOutcomeTimeFrame":"16 time points up to 96 hours" },{ "SecondaryOutcomeMeasure":"Safety: Incidence of adverse events", "SecondaryOutcomeTimeFrame":"approximately 50 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale and female healthy volunteers, 18 to 45 years of age inclusive\nBody mass index (BMI) 18.0 to 32.0 kg/m2\nWeight >/= 50 kg\nHealthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination\nNonsmoker\nFemales of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)\n\nExclusion Criteria:\n\nPregnant or lactating females\nPositive results for drugs of abuse in the urine at screening or prior to admission to the clinical site during any study period\nPositive for hepatitis B, hepatitis C or HIV infection\nCurrent smokers or subjects who have discontinued smoking less than 6 months prior to the first dose of study medication\nUse of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication\nRoutine chronic use of more than 2 g acetaminophen daily\nUse of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer\nHistory of clinically significant disease or disorder\nHistory of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity\nHistory (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Hoffmann-La Roche", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Lenexa", "LocationState":"Kansas", "LocationZip":"66219", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"23712757", "ReferenceType":"derived", "ReferenceCitation":"Brennan BJ, Moreira SA, Morcos PN, Navarro MT, Asthappan J, Goelzer P, Weigl P, Smith PF. Pharmacokinetics of a three-way drug interaction between danoprevir, ritonavir and the organic anion transporting polypeptide (OATP) inhibitor ciclosporin. Clin Pharmacokinet. 2013 Sep;52(9):805-13. doi: 10.1007/s40262-013-0077-2." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000016572", "InterventionMeshTerm":"Cyclosporine" },{ "InterventionMeshId":"D000019438", "InterventionMeshTerm":"Ritonavir" },{ "InterventionMeshId":"D000003524", "InterventionMeshTerm":"Cyclosporins" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000935", "InterventionAncestorTerm":"Antifungal Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000065095", "InterventionAncestorTerm":"Calcineurin Inhibitors" },{ "InterventionAncestorId":"D000017320", "InterventionAncestorTerm":"HIV Protease Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000019380", "InterventionAncestorTerm":"Anti-HIV Agents" },{ "InterventionAncestorId":"D000044966", "InterventionAncestorTerm":"Anti-Retroviral Agents" },{ "InterventionAncestorId":"D000000998", "InterventionAncestorTerm":"Antiviral Agents" },{ "InterventionAncestorId":"D000065692", "InterventionAncestorTerm":"Cytochrome P-450 CYP3A Inhibitors" },{ "InterventionAncestorId":"D000065607", "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M17544", "InterventionBrowseLeafName":"Cyclosporine", "InterventionBrowseLeafAsFound":"Cyclosporine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M5313", "InterventionBrowseLeafName":"Cyclosporins", "InterventionBrowseLeafAsFound":"Cyclosporine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M19978", "InterventionBrowseLeafName":"Ritonavir", "InterventionBrowseLeafAsFound":"Ritonavir", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2835", "InterventionBrowseLeafName":"Antifungal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4835", "InterventionBrowseLeafName":"Clotrimazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10379", "InterventionBrowseLeafName":"Miconazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5657", "InterventionBrowseLeafName":"Dermatologic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29039", "InterventionBrowseLeafName":"Calcineurin Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19934", "InterventionBrowseLeafName":"Anti-HIV Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24015", "InterventionBrowseLeafName":"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2895", "InterventionBrowseLeafName":"Antiviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29151", "InterventionBrowseLeafName":"Cytochrome P-450 CYP3A Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29124", "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } } } } } }