{
  "FullStudy":{
    "Rank":217901,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515358",
          "OrgStudyIdInfo":{
            "OrgStudyId":"14340"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"I5U-MC-ANBB",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Eli Lilly and Company"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Eli Lilly and Company",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants",
          "OfficialTitle":"A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 30, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 31, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Eli Lilly and Company",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy Volunteers"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"18",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Single dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"LY3000328",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Single escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: LY3000328"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Administered orally",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"LY3000328",
                "InterventionDescription":"Administered orally",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "LY3000328"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of participants with one or more drug related adverse events (AEs) or any serious AEs",
                "PrimaryOutcomeTimeFrame":"Baseline to study completion (estimate 3 months)"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328",
                "SecondaryOutcomeTimeFrame":"Pre-dose up to Day 6 post-dose"
              },{
                "SecondaryOutcomeMeasure":"Pharmacokinetics: Maximum concentration (Cmax) of LY3000328",
                "SecondaryOutcomeTimeFrame":"Pre-dose up to Day 6 post-dose"
              },{
                "SecondaryOutcomeMeasure":"Change in Cathepsin S (CatS) activity",
                "SecondaryOutcomeTimeFrame":"Pre-dose, up to 48 hours post-dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAre overtly healthy males or females, as determined by medical history and physical examination",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"35 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)",
                "OverallOfficialAffiliation":"Eli Lilly and Company",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.",
                "LocationCity":"Singapore",
                "LocationZip":"117597",
                "LocationCountry":"Singapore"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}