{
  "FullStudy":{
    "Rank":218173,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511783",
          "OrgStudyIdInfo":{
            "OrgStudyId":"E2609-A001-002"
          },
          "Organization":{
            "OrgFullName":"Eisai Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects",
          "OfficialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of E2609 in Healthy Subjects"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 2, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 3, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Eisai Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered to healthy elderly subjects."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"E2609",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"E2609 at ascending doses",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: E2609"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"E2609",
                "InterventionDescription":"E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "E2609"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Incidence of adverse events",
                "PrimaryOutcomeTimeFrame":"19 days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Plasma Cmax and AUC (0-24h) of E2609 on Day 1 and Day 14",
                "SecondaryOutcomeTimeFrame":"20 days"
              },{
                "SecondaryOutcomeMeasure":"Plasma Aβ(1-x) Amax (defined as maximum change (%) of E2609 levels compared to time-matched baseline at a single time point within 24 hours postdose) in plasma and cerebrospinal fluid, plasma and CSF",
                "SecondaryOutcomeTimeFrame":"20 days"
              },{
                "SecondaryOutcomeMeasure":"Time at which Amax occurs for plasma Aβ(1-x)",
                "SecondaryOutcomeTimeFrame":"20 days"
              },{
                "SecondaryOutcomeMeasure":"Area under the plasma Aβ(1-x) concentration, AUAC(0-24h), by time curve from time 0 to time 24 hours on Day -1, Day 1, and Day 14",
                "SecondaryOutcomeTimeFrame":"20 days"
              },{
                "SecondaryOutcomeMeasure":"Change (%) in plasma Aβ(1-x) AUAC within 24 hours comparing Day 1 to Day -1 and Day 14 to Day -1",
                "SecondaryOutcomeTimeFrame":"20 days"
              },{
                "SecondaryOutcomeMeasure":"Percent change of Aβ(1-x) in CSF from Day -2 to Day 14",
                "SecondaryOutcomeTimeFrame":"20 days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Key Inclusion Criteria:\n\nHealthy males and females\nFemale subjects must be of non-childbearing potential\nAged 50 to 85 years, inclusive BMI of 18 to 32 kg/m2 at screening\nThyroid function tests within normal rangeMini-Mental State Examination score of 28-30, inclusive\n\nKey Exclusion Criteria:\n\nHistory of neurological abnormalities, including seizures\nAny clinically significant abnormality of the ECG at Screening and Baseline including QTc prolongation\nHistory of ischemic heart disease, cardiac arrhythmias, cerebrovascular diseases\nOther medical conditions that are not stably controlled\nPresence of orthostatic hypotension",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"50 Years",
          "MaximumAge":"85 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Craig Curtis",
                "OverallOfficialAffiliation":"Compass Research Phase 1, LLC",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Compass Research Phase 1, LLC",
                "LocationCity":"Orlando",
                "LocationState":"Florida",
                "LocationZip":"32806",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}