{
  "FullStudy":{
    "Rank":218010,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513928",
          "OrgStudyIdInfo":{
            "OrgStudyId":"B1621005"
          },
          "Organization":{
            "OrgFullName":"Pfizer",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects",
          "OfficialTitle":"A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04937319 In Overweight And Obese Otherwise Healthy Subjects"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 8, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 12, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Pfizer",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "pharmacokinetics",
              "relative bioavailability",
              "formulation comparison"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Pf-04937319",
                "InterventionDescription":"Formulation A) Pf-04937319 50 mg - administered as tablet"
              },{
                "InterventionType":"Drug",
                "InterventionName":"Pf-04937319",
                "InterventionDescription":"Formulation B) Pf-04937319 50 mg - administered as capsule"
              },{
                "InterventionType":"Drug",
                "InterventionName":"Pf-04937319",
                "InterventionDescription":"Formulation C) Pf-04937319 50 mg - administered as capsule"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Pf-04937319: Maximum plasma concentration (Cmax)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"Pf-04937319: Time for Cmax (Tmax)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"Pf-04937319: terminal half-life (T1/2)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"PF-06455349: Maximum Observed Plasma Concentration (Cmax)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              },{
                "PrimaryOutcomeMeasure":"PF-06455349: Plasma Decay Half-Life (t1/2)",
                "PrimaryOutcomeTimeFrame":"0 - 96 hours post dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy male and/or female subjects between the ages of 21 and 55 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.\nSubjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.\nBody Mass Index (BMI) of 23 to 33 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 (excluding untreated seasonal allergies).\nAny condition possibly affecting drug absorption (eg, gastrectomy).\nA positive urine drug screen.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"21 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Pfizer CT.gov Call Center",
                "OverallOfficialAffiliation":"Pfizer",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Pfizer Investigational Site",
                "LocationCity":"Singapore",
                "LocationZip":"188770",
                "LocationCountry":"Singapore"
              }
            ]
          }
        },
        "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=B1621005&StudyName=Astudy%20To%20Compare%20The%20Pharmacokinetics%20Of%20Different%20Formulations%20Of%20PF-04937319%20In%20Healthy%20Subjects"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}