{
  "FullStudy":{
    "Rank":218194,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511510",
          "OrgStudyIdInfo":{
            "OrgStudyId":"B1701007"
          },
          "Organization":{
            "OrgFullName":"Biogen",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers",
          "OfficialTitle":"A Phase I, Randomized, Subject And Investigator Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"July 19, 2011",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 19, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 21, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Biogen",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.",
          "DetailedDescription":"This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Schizophrenia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "PF-04958242",
              "multiple dose",
              "safety",
              "schizophrenia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"39",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PF-04958242",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: PF-04958242"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"PF-04958242",
                "InterventionDescription":"PF-04958242 0.05 mg oral solution Q24 hours for 14 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PF-04958242"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"PF-04958242",
                "InterventionDescription":"PF-04958242 0.10 mg oral solution Q24 hours for 14 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PF-04958242"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"PF-04958242",
                "InterventionDescription":"PF-04958242 0.15 mg oral solution Q24 hours for 14 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PF-04958242"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"PF-04958242",
                "InterventionDescription":"PF-04958242 0.25 mg oral solution Q24 hours for 14 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PF-04958242"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Placebo oral solution Q24 hours for 14 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1",
                "PrimaryOutcomeTimeFrame":"Day 1-Day 2"
              },{
                "PrimaryOutcomeMeasure":"Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4",
                "PrimaryOutcomeTimeFrame":"Day 4"
              },{
                "PrimaryOutcomeMeasure":"Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7",
                "PrimaryOutcomeTimeFrame":"Day 7"
              },{
                "PrimaryOutcomeMeasure":"Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14",
                "PrimaryOutcomeTimeFrame":"Day 14-Day 18"
              },{
                "PrimaryOutcomeMeasure":"Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14",
                "PrimaryOutcomeTimeFrame":"Day 14-Day 15"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Drug Effect Questionaire Liking scale",
                "SecondaryOutcomeTimeFrame":"Day 14"
              },{
                "SecondaryOutcomeMeasure":"Digit Symbol Substitution Test",
                "SecondaryOutcomeTimeFrame":"Day 14"
              },{
                "SecondaryOutcomeMeasure":"Columbia Suicide Severity Rating Scale",
                "SecondaryOutcomeTimeFrame":"Day 0-Day 14"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)\n\nExclusion Criteria:\n\nEvidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease\nHistory of seizures or of a condition with risk of seizures\nPregnant or nursing females, and females of child bearing potential",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Medical Director",
                "OverallOfficialAffiliation":"Biogen",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Pfizer Investigational Site",
                "LocationCity":"New Haven",
                "LocationState":"Connecticut",
                "LocationZip":"06511",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"To obtain contact information for a study center near you, click here.",
                "SeeAlsoLinkURL":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701007&StudyName=Study%20to%20Evaluate%20the%20Safety%2C%20Tolerability%20and%20Pharmacokinetics%20of%20Repeated%20Doses%20of%20PF-04958242%20in%20Healthy%20Volunteers%20"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012559",
                "ConditionMeshTerm":"Schizophrenia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019967",
                "ConditionAncestorTerm":"Schizophrenia Spectrum and Other Psychotic Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13959",
                "ConditionBrowseLeafName":"Schizophrenia",
                "ConditionBrowseLeafAsFound":"Schizophrenia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20422",
                "ConditionBrowseLeafName":"Schizophrenia Spectrum and Other Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}