{
  "FullStudy":{
    "Rank":217612,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519128",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CR100750"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"TMC278IFD1001",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Janssen R&D Ireland"
              },{
                "SecondaryId":"2011-004159-38",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Janssen R&D Ireland",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin",
          "OfficialTitle":"A Phase I, Open Label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Effect of Steady-state TMC278 on the Pharmacokinetics of a Single Dose of Digoxin"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 27, 2011",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 1, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 4, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Janssen R&D Ireland",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.",
          "DetailedDescription":"This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study to investigate the effect of steady-state TMC278 on the single dose pharmacokinetics of digoxin. The study consists of 3 phases, including screening phase, treatment phase, and follow-up phase. After the screening phase, participants will be randomized to one of 2 treatment sequences consisting of Treatments A and B, ie, Sequence AB (11 participants), and Sequence BA (11 participants). Treatment phase includes, Treatment A: digoxin 0.5 mg (single oral dose), and Treatment B: TMC278 25 mg once daily with digoxin 0.5 mg (single oral dose). The 2 consecutive sequences will be separated by a washout period (period when receiving no treatment) of at least 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiograms, cardiac telemetry, vital signs, physical examination, alcohol breath test, and specific toxicities will be monitored throughout the study.The study duration for treatment phase will be at least 26 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Healthy",
              "TMC278",
              "TMC278IFD1001",
              "Human immunodeficiency virus - type 1",
              "Pharmacokinetics",
              "Digoxin"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"22",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Treatment sequence AB",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"In Treatment A, digoxin 0.5 mg (single oral dose) will be administered on Day 1. In Treatment B, TMC278 at 25 mg, once daily will be administered for 16 days, with digoxin 0.5 mg (single oral dose) administered in the morning on Day 11.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Treatment A: Digoxin",
                    "Drug: Treatment B: TMC278"
                  ]
                }
              },{
                "ArmGroupLabel":"Treatment sequence BA",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"In Treatment B, TMC278 at 25 mg, once daily will be administered for 16 days, with digoxin 0.5 mg (single oral dose) administered in the morning on Day 11. In Treatment A, digoxin 0.5 mg (single oral dose) will be administered on Day 1.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Treatment A: Digoxin",
                    "Drug: Treatment B: TMC278"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Treatment A: Digoxin",
                "InterventionDescription":"Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Treatment sequence AB",
                    "Treatment sequence BA"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Digoxin"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Treatment B: TMC278",
                "InterventionDescription":"Type=exact number, unit=mg, number=25, form=tablet, route=oral. TMC278 administered for 16 days, with digoxin administered in the morning on Day 11.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Treatment sequence AB",
                    "Treatment sequence BA"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "TMC278"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Maximum plasma concentration (Cmax) of digoxin following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin",
                "PrimaryOutcomeDescription":"Pharmacokinetic parameter Cmax of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.",
                "PrimaryOutcomeTimeFrame":"Up to 46 Days"
              },{
                "PrimaryOutcomeMeasure":"Area under the plasma concentration versus time curve (AUC) of digoxin following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin",
                "PrimaryOutcomeDescription":"Pharmacokinetic parameter AUC of digoxin was measured following single dose administration of digoxin co-administered with TMC278, compared to single dose administration of digoxin.",
                "PrimaryOutcomeTimeFrame":"Up to 46 Days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of participants with adverse events",
                "SecondaryOutcomeTimeFrame":"Up to 58 Days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nWomen must be postmenopausal for at least 2 years, or be surgically sterile\nMen must agree to use a highly effective method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study medication\n\nExclusion Criteria:\n\nA positive HIV-1 or HIV-2 test at screening\nHepatitis A, B or C infection at screening\nHistory of clinically relevant heart rhythm disturbances\nHistory of idiopathic hypertrophic subaortic stenosis, atrioventricular block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Janssen R&D Ireland Clinical Trial",
                "OverallOfficialAffiliation":"Janssen R&D Ireland",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Merksem",
                "LocationCountry":"Belgium"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the effect of steady-state TMC278 on the pharmacokinetics of a single dose of digoxin.",
                "SeeAlsoLinkURL":"http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3415&filename=CR100750_CSR.pdf"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000068696",
                "InterventionMeshTerm":"Rilpivirine"
              },{
                "InterventionMeshId":"D000004077",
                "InterventionMeshTerm":"Digoxin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000889",
                "InterventionAncestorTerm":"Anti-Arrhythmia Agents"
              },{
                "InterventionAncestorId":"D000002316",
                "InterventionAncestorTerm":"Cardiotonic Agents"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000020011",
                "InterventionAncestorTerm":"Protective Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018894",
                "InterventionAncestorTerm":"Reverse Transcriptase Inhibitors"
              },{
                "InterventionAncestorId":"D000019384",
                "InterventionAncestorTerm":"Nucleic Acid Synthesis Inhibitors"
              },{
                "InterventionAncestorId":"D000044966",
                "InterventionAncestorTerm":"Anti-Retroviral Agents"
              },{
                "InterventionAncestorId":"D000000998",
                "InterventionAncestorTerm":"Antiviral Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000019380",
                "InterventionAncestorTerm":"Anti-HIV Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M295",
                "InterventionBrowseLeafName":"Rilpivirine",
                "InterventionBrowseLeafAsFound":"TMC278",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M5848",
                "InterventionBrowseLeafName":"Digoxin",
                "InterventionBrowseLeafAsFound":"Digoxin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2794",
                "InterventionBrowseLeafName":"Anti-Arrhythmia Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4154",
                "InterventionBrowseLeafName":"Cardiotonic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M20453",
                "InterventionBrowseLeafName":"Protective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19519",
                "InterventionBrowseLeafName":"Reverse Transcriptase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M24015",
                "InterventionBrowseLeafName":"Anti-Retroviral Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2895",
                "InterventionBrowseLeafName":"Antiviral Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19934",
                "InterventionBrowseLeafName":"Anti-HIV Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"AnArAg",
                "InterventionBrowseBranchName":"Anti-Arrhythmia Agents"
              },{
                "InterventionBrowseBranchAbbrev":"CaAg",
                "InterventionBrowseBranchName":"Cardiotonic Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8782",
                "ConditionBrowseLeafName":"Immunologic Deficiency Syndromes",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16833",
                "ConditionBrowseLeafName":"HIV Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2103",
                "ConditionBrowseLeafName":"Acquired Immunodeficiency Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              }
            ]
          }
        }
      }
    }
  }
}