{
  "FullStudy":{
    "Rank":217645,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518699",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Ha02-005"
          },
          "Organization":{
            "OrgFullName":"Hatchtech Pty Ltd",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers",
          "OfficialTitle":"A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Male and Female Adult Subjects, Preceded by a Dose-Escalation Study to Determine the Supratherapeutic Dose of Ha44"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 22, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 23, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hatchtech Pty Ltd",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pediculosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"81",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Part 1 Group 1",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Low dose study drug in 6 of 8 subjects Placebo in 2 of 8 subjects",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ha44",
                    "Drug: Ha44 Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Part 1 Group 2",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Mid dose study drug in 6 of 8 subjects Placebo in 2 of 8 subjects",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ha44",
                    "Drug: Ha44 Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Part 1 Group 3",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"High dose study drug in 6 or 8 subjects Placebo in 2 of 8 subjects",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ha44",
                    "Drug: Ha44 Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Part 2 Group A",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Study drug plus positive-control placebo",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Ha44",
                    "Drug: Moxifloxacin Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Part 2 Group B",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Placebo plus positive-control placebo",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Moxifloxacin Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Part 2 Group C",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Placebo plus positive control",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Moxifloxacin"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Ha44",
                "InterventionDescription":"study drug at low, moderate and high dose single exposure",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Part 1 Group 1",
                    "Part 1 Group 2",
                    "Part 1 Group 3",
                    "Part 2 Group A"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Ha44 Placebo",
                "InterventionDescription":"Ha44 Vehicle Gel without Ha44",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Part 1 Group 1",
                    "Part 1 Group 2",
                    "Part 1 Group 3"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Moxifloxacin Placebo",
                "InterventionDescription":"Moxifloxacin Placebo",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Part 2 Group A",
                    "Part 2 Group B"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Moxifloxacin",
                "InterventionDescription":"moxifloxacin 400mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Part 2 Group C"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Part 1: safety and tolerability of single applications of Ha44",
                "PrimaryOutcomeDescription":"safety and tolerability of single applications of Ha44 of increasing exposure duration assessed by the following measures: AEs, application site reactions, blood pressure and other vital sign measurements, 12 lead ECGs, incidence and magnitude of clinically significant changes from baseline in clinical laboratory values (hematology, chemistry, and urinalysis), and physical examinations.",
                "PrimaryOutcomeTimeFrame":"6 months"
              },{
                "PrimaryOutcomeMeasure":"Part 2: difference between the post-dose time matched baseline adjusted mean QTcF (Ha44 0.74% Gel) and the post dose time-matched baseline adjusted mean QTcF (placebo)",
                "PrimaryOutcomeDescription":"The primary endpoint for Part 2 is the difference between the post-dose time matched baseline adjusted mean QTcF (Ha44 0.74% Gel) and the post dose time-matched baseline adjusted mean QTcF (placebo) = [ΔQTcF (Ha44 0.74% Gel) - ΔQTcF (placebo)] = ΔΔQTcF.",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Part 1: PK parameters",
                "SecondaryOutcomeDescription":"PK parameters: Cmax, Tmax area under the curve from time zero to the last quantifiable sample AUClast) and also extrapolated to infinity (AUCinf), and the terminal-phase rate constant and half life (t½).",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Part 2: The effect of Ha44 0.74% Gel compared to placebo on cardiac parameters",
                "SecondaryOutcomeDescription":"Part 2: The effect of Ha44 0.74% Gel compared to placebo on QTcB, heart rate, PR interval, RR interval, QRS interval, uncorrected QT interval, change in ST and T-wave morphology, categorical change in QTc variables, and correlation between the QTcF change from baseline and plasma concentrations.",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nhealthy male or female subject, 18 to 50 years of age, inclusive, at least 45 kg and has a body mass index (BMI) of 18 to 33 kg/m2,\nFemale subjects of childbearing potential must not be pregnant and not lactating or prepared to practice highly effective birth control methods\nThe subject has normal 12-lead ECG results or, if abnormal, the abnormality is not clinically significant (as determined by the investigator).\n\nExclusion Criteria:\n\nhas evidence of cardiac conduction abnormalities\nhistory of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative due to cardiac causes at a young age\npotassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal\nlaboratory test results at Screening are >2 x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), >1.5 x ULN for bilirubin, or >1.5 x ULN for creatinine\nhistory or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)\nfebrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week before clinic admission\nsupine mean systolic blood pressure <90 or >140 mmHg and a mean diastolic blood pressure <50 or >90 mmHg\npositive for HIV or hepatitis C antibody or hepatitis B antigen (HBsAg)",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Albert Dietz, MD",
                "OverallOfficialAffiliation":"Spaulding Clinical",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Spaulding Clinical",
                "LocationCity":"West Bend",
                "LocationState":"Wisconsin",
                "LocationZip":"53095",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077266",
                "InterventionMeshTerm":"Moxifloxacin"
              },{
                "InterventionMeshId":"C000109079",
                "InterventionMeshTerm":"Norgestimate, ethinyl estradiol drug combination"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000900",
                "InterventionAncestorTerm":"Anti-Bacterial Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000059005",
                "InterventionAncestorTerm":"Topoisomerase II Inhibitors"
              },{
                "InterventionAncestorId":"D000059003",
                "InterventionAncestorTerm":"Topoisomerase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000003277",
                "InterventionAncestorTerm":"Contraceptives, Oral, Combined"
              },{
                "InterventionAncestorId":"D000003276",
                "InterventionAncestorTerm":"Contraceptives, Oral"
              },{
                "InterventionAncestorId":"D000003271",
                "InterventionAncestorTerm":"Contraceptive Agents, Female"
              },{
                "InterventionAncestorId":"D000003270",
                "InterventionAncestorTerm":"Contraceptive Agents"
              },{
                "InterventionAncestorId":"D000012102",
                "InterventionAncestorTerm":"Reproductive Control Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1722",
                "InterventionBrowseLeafName":"Moxifloxacin",
                "InterventionBrowseLeafAsFound":"Moxifloxacin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M140649",
                "InterventionBrowseLeafName":"Norgestimate, ethinyl estradiol drug combination",
                "InterventionBrowseLeafAsFound":"Moxifloxacin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M204621",
                "InterventionBrowseLeafName":"Estradiol 3-benzoate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M237310",
                "InterventionBrowseLeafName":"Estradiol 17 beta-cypionate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M6691",
                "InterventionBrowseLeafName":"Estradiol",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M242995",
                "InterventionBrowseLeafName":"Polyestradiol phosphate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M6728",
                "InterventionBrowseLeafName":"Ethinyl Estradiol",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M211303",
                "InterventionBrowseLeafName":"Norgestimate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M5077",
                "InterventionBrowseLeafName":"Contraceptive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M5083",
                "InterventionBrowseLeafName":"Contraceptives, Oral",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M5084",
                "InterventionBrowseLeafName":"Contraceptives, Oral, Combined",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Repr",
                "InterventionBrowseBranchName":"Reproductive Control Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000010373",
                "ConditionMeshTerm":"Lice Infestations"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004478",
                "ConditionAncestorTerm":"Ectoparasitic Infestations"
              },{
                "ConditionAncestorId":"D000012876",
                "ConditionAncestorTerm":"Skin Diseases, Parasitic"
              },{
                "ConditionAncestorId":"D000010272",
                "ConditionAncestorTerm":"Parasitic Diseases"
              },{
                "ConditionAncestorId":"D000012874",
                "ConditionAncestorTerm":"Skin Diseases, Infectious"
              },{
                "ConditionAncestorId":"D000012871",
                "ConditionAncestorTerm":"Skin Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11867",
                "ConditionBrowseLeafName":"Lice Infestations",
                "ConditionBrowseLeafAsFound":"Pediculosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11768",
                "ConditionBrowseLeafName":"Parasitic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14257",
                "ConditionBrowseLeafName":"Skin Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14262",
                "ConditionBrowseLeafName":"Skin Diseases, Parasitic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14260",
                "ConditionBrowseLeafName":"Skin Diseases, Infectious",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC03",
                "ConditionBrowseBranchName":"Parasitic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              }
            ]
          }
        }
      }
    }
  }
}