{
  "FullStudy":{
    "Rank":218064,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513200",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SPIRI-155"
          },
          "Organization":{
            "OrgFullName":"Stealth BioTherapeutics Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia",
          "OfficialTitle":"A Two Part Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers and the Effects of Bendavia™ and Unfractionated Heparin When Administered Concurrently"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 17, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Stealth BioTherapeutics Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy Volunteers"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"UFH + Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"UFH (60U/kg bolus followed by 12U/kg/hr for approx.11 hours) with saline (placebo) administered as infusion for the last 4 hours of UFH",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Unfractionated heparin (UFH)",
                    "Drug: Saline (0.9%, sterile, for infusion)"
                  ]
                }
              },{
                "ArmGroupLabel":"UFH + Bendavia",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"UFH (60U/kg bolus followed by 12U/kg/hr for approx.11 hours) with Bendavia (0.25mg/kg/hr) administered as infusion for the last 4 hours of UFH",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Unfractionated heparin (UFH)",
                    "Drug: Bendavia"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Unfractionated heparin (UFH)",
                "InterventionDescription":"UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "UFH + Bendavia",
                    "UFH + Placebo"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Bendavia",
                "InterventionDescription":"Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "UFH + Bendavia"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Saline (0.9%, sterile, for infusion)",
                "InterventionDescription":"Saline (placebo) Constant IV infusion for 4 hours",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "UFH + Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia",
                "PrimaryOutcomeDescription":"Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (Analysis of Variance; ANOVA) at the following time points:\n\nPre-UFH, Pre-Study-Drug infusion start and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours Post-Study-Drug infusion start.",
                "PrimaryOutcomeTimeFrame":"Pre-UFH to 24 hours post-study drug administration"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Mean difference over 12 hours of anti-factor Xa (IU/mL) when UFH is administered with and without Bendavia",
                "SecondaryOutcomeDescription":"Difference in group (with/without Bendavia) means of aPPT values will be assessed for statistical significance (ANOVA) at the following time points:\n\nPre-UFH, Pre-Study-Drug infusion start and 4, 8 and 12 hours Post-Study-Drug infusion start.",
                "SecondaryOutcomeTimeFrame":"Pre-UFH to 12 hours post-study drug administration"
              },{
                "SecondaryOutcomeMeasure":"Mean difference in Bendavia Area Under the Curve(0-infinity) (AUC) when Bendavia is administered with and without UFH (historical data will be used to provide bendavia without UFH)",
                "SecondaryOutcomeTimeFrame":"48 hours post-study-drug administration"
              },{
                "SecondaryOutcomeMeasure":"Difference in number of adverse events when UFH is administered with and without Bendavia",
                "SecondaryOutcomeDescription":"Adverse events will be described by treatment group (UFH with and without Bendavia). No statistical analysis of the difference between AEs will be conducted.",
                "SecondaryOutcomeTimeFrame":"Pre-dose through Day 10"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy adult males or females aged between 18 and 65 years of age with signed informed consent.\nWomen who are not post-menopausal (without menstrual bleed for >24 months) or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment with understanding (through informed consent process) to not become pregnant over the duration of the study and must agree to employ an effective form of birth control for the duration of the study [Acceptable forms of birth control are: double-barrier contraceptives (condom, diaphragm with spermicide) or intra-uterine device (IUD) 1 week prior to and at least 30 days post treatment even if hormonal contraceptives are used]\n\nExclusion Criteria:\n\nSerum sodium level below the lower limit of the site's clinical laboratory normal range at both study period qualification visits,\nPlatelet value below the lower limit of normal range at screening or admission,\naPTT value outside the normal range at screening or admission,\nCreatinine clearance calculated by the Cockcroft and Gault method calculated to be <90 mL/min for males and <80 mL/min for females,\nAny addition laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening,\nClinically significant abnormalities on physical examination,\nBody Mass Index (BMI) of less than 18 kg/m2 or greater than 32 kg/m2,\nAny disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,\nHistory of seizures or history of epilepsy,\nHistory of serious (Principal Investigator judgment) mental illness,\nReceipt of investigational medicinal product within 30 days before planned date of unfractionated heparin and/or study drug administration,\nPositive serology for human immunodeficiency virus 1 or 2 (HIV1 or 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV),\nFever greater than 37.5°C at the time of planned dosing,\nSuspicion of or recent history of alcohol or substance abuse,\nDonated blood or blood products within the past 30 days,\nWomen who are pregnant or breastfeeding,\nEmployee or family member of the investigational site,\nSubjects who currently smoke cigarettes, cigars, pipes or chew tobacco products or who have used any tobacco products in the 30 days prior to screening,\n\nSubjects who are either unwilling to agree to refrain from using or found to be using:\n\nAlcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period\nPrescription medications from 14 days prior to and 7 days post treatment (excluding hormonal contraceptives)\nHormonal contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment\nSubjects taking aspirin or any other non-steroidal anti-inflammatory agent, either prescription or over-the-counter, within 10 days of treatment,\nSubjects known to have allergic or untoward effects when using unfractionated heparin,\nSubjects having previous exposure to Bendavia,\nSubjects who are expected to undergo any surgical procedure within 14 days of the completion of the study.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Kenneth C Lasseter, MD",
                "OverallOfficialAffiliation":"Clinical Pharmacology of Miami",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Richard Straube, MD",
                "OverallOfficialAffiliation":"Stealth Peptides",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Clinical Pharmacology of Miami",
                "LocationCity":"Miami",
                "LocationState":"Florida",
                "LocationZip":"33014-3616",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000006493",
                "InterventionMeshTerm":"Heparin"
              },{
                "InterventionMeshId":"C000006871",
                "InterventionMeshTerm":"Calcium heparin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000925",
                "InterventionAncestorTerm":"Anticoagulants"
              },{
                "InterventionAncestorId":"D000005343",
                "InterventionAncestorTerm":"Fibrinolytic Agents"
              },{
                "InterventionAncestorId":"D000050299",
                "InterventionAncestorTerm":"Fibrin Modulating Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M8162",
                "InterventionBrowseLeafName":"Heparin",
                "InterventionBrowseLeafAsFound":"Unfractionated heparin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M45199",
                "InterventionBrowseLeafName":"Calcium heparin",
                "InterventionBrowseLeafAsFound":"Unfractionated heparin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M3963",
                "InterventionBrowseLeafName":"Calcium",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M3980",
                "InterventionBrowseLeafName":"Calcium, Dietary",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2825",
                "InterventionBrowseLeafName":"Anticoagulants",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7056",
                "InterventionBrowseLeafName":"Fibrinolytic Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"FiAg",
                "InterventionBrowseBranchName":"Fibrinolytic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"AnCoag",
                "InterventionBrowseBranchName":"Anticoagulants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"BDCA",
                "InterventionBrowseBranchName":"Bone Density Conservation Agents"
              }
            ]
          }
        }
      }
    }
  }
}