{
  "FullStudy":{
    "Rank":218195,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511497",
          "OrgStudyIdInfo":{
            "OrgStudyId":"B0141008"
          },
          "Organization":{
            "OrgFullName":"Pfizer",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers",
          "OfficialTitle":"A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"October 18, 2011",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 20, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 21, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Pfizer",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pain",
              "Migraine Disorders"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Phase 1",
              "PF-04427429"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"31",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PF-04427429",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: PF-04427429"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Normal saline",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Normal saline"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"PF-04427429",
                "InterventionDescription":"Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PF-04427429"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Normal saline",
                "InterventionDescription":"Intravenous, normal saline",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              },{
                "PrimaryOutcomeMeasure":"Incidence and severity of clinical laboratory abnormalities.",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              },{
                "PrimaryOutcomeMeasure":"Mean change from baseline and placebo in blood pressure (BP).",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              },{
                "PrimaryOutcomeMeasure":"Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              },{
                "PrimaryOutcomeMeasure":"Categorical summary of QTcF compared to baseline between dose groups and placebo.",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              },{
                "PrimaryOutcomeMeasure":"Anti-Drug Antibodies (ADA) responses.",
                "PrimaryOutcomeTimeFrame":"From Day 0 up to Day 168 and until levels return to baseline."
              },{
                "PrimaryOutcomeMeasure":"Intravenous (IV) injection site reactions.",
                "PrimaryOutcomeTimeFrame":"Day 1 post dose"
              },{
                "PrimaryOutcomeMeasure":"Mean change from baseline and placebo in pulse rate (PR).",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              },{
                "PrimaryOutcomeMeasure":"Mean change from baseline and placebo in body temperature.",
                "PrimaryOutcomeTimeFrame":"Screening up to Day 168"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Area under the concentration-time curve from zero to infinite time postdose (AUCinf).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              },{
                "SecondaryOutcomeMeasure":"Time to maximum concentration (Tmax).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              },{
                "SecondaryOutcomeMeasure":"Maximum concentration (Cmax).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              },{
                "SecondaryOutcomeMeasure":"Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              },{
                "SecondaryOutcomeMeasure":"Terminal elimination half-life (t½).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              },{
                "SecondaryOutcomeMeasure":"Clearance (CL).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              },{
                "SecondaryOutcomeMeasure":"Volume of distribution (Vz).",
                "SecondaryOutcomeTimeFrame":"Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nGenerally healthy women, of non-child bearing potential, between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.\nBody Mass Index (BMI) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.\n\nExclusion Criteria:\n\nEvidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.\nWomen of childbearing potential.\nHistory or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Pfizer CT.gov Call Center",
                "OverallOfficialAffiliation":"Pfizer",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Pfizer Investigational Site",
                "LocationCity":"Miami",
                "LocationState":"Florida",
                "LocationZip":"33126",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Pfizer Investigational Site",
                "LocationCity":"Miami",
                "LocationState":"Florida",
                "LocationZip":"33134",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Pfizer Investigational Site",
                "LocationCity":"Dallas",
                "LocationState":"Texas",
                "LocationZip":"75247",
                "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=B0141008&StudyName=Safety%2C%20Tolerability%2C%20Pharmacokinetics%2C%20and%20Pharmacodynamics%20Study%20Of%20PF-04427429%20In%20Healthy%20Women%20Volunteers"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008881",
                "ConditionMeshTerm":"Migraine Disorders"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000051270",
                "ConditionAncestorTerm":"Headache Disorders, Primary"
              },{
                "ConditionAncestorId":"D000020773",
                "ConditionAncestorTerm":"Headache Disorders"
              },{
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M10435",
                "ConditionBrowseLeafName":"Migraine Disorders",
                "ConditionBrowseLeafAsFound":"Migraine Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7934",
                "ConditionBrowseLeafName":"Headache",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21113",
                "ConditionBrowseLeafName":"Headache Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M25244",
                "ConditionBrowseLeafName":"Headache Disorders, Primary",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}