{
  "FullStudy":{
    "Rank":217731,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517568",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NN2211-1699"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2006-002293-22",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Metabolism and Excretion of Liraglutide in Healthy Male Volunteers",
          "OfficialTitle":"A Single-Centre, Open Label Trial Investigating the Metabolites in Plasma, Urine and Faeces After a Single Subcutaneous Dose of [3H]-Liraglutide to Healthy Subjects"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2006",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2006",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 21, 2012",
          "StudyFirstSubmitQCDate":"January 21, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 25, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 26, 2017",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Novo Nordisk A/S",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This trial is conducted in Europe. The aim of this trial is characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of [3H]-liraglutide."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes",
              "Healthy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"7",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Liraglutide",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide [3H]"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"liraglutide [3H]",
                "InterventionDescription":"A single dose of 0.75 mg will be given as a subcutaneous injection",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Liraglutide"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "[3H]-liraglutide"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces"
              },{
                "PrimaryOutcomeMeasure":"Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Area under the curve"
              },{
                "SecondaryOutcomeMeasure":"Cmax, maximum concentration"
              },{
                "SecondaryOutcomeMeasure":"tmax, time to reach Cmax"
              },{
                "SecondaryOutcomeMeasure":"t½, terminal half-life"
              },{
                "SecondaryOutcomeMeasure":"The distribution of [3H]-liraglutide in whole blood versus plasma"
              },{
                "SecondaryOutcomeMeasure":"Adverse events"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nGood general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments\nBMI (Boday Mass Index) of 20.0-27.0 kg/m^2, both inclusive\n\nExclusion Criteria:\n\nHistory of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator\nImpaired renal function\nActive hepatitis B or active hepatitis C\nPositive human immunodeficiency virus (HIV) antibodies\nAny clinically significant abnormal ECG, as judged by the Investigator\nAny clinically significant abnormal laboratory test results, as judged by the Investigator\nAcute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator\nKnown or suspected allergy to trial product(s) or related products\nHistory of alcoholism or drug abuse or positive results in alcohol and drug screens\nSmoking of more than 5 cigarettes per day\nHabitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator\nExcessive consumption of a diet deviating from a normal diet, as judged by the Investigator",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"30 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Global Clinical Registry (GCR, 1452)",
                "OverallOfficialAffiliation":"Novo Nordisk A/S",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Novo Nordisk Investigational Site",
                "LocationCity":"Groningen",
                "LocationZip":"9728 NZ",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"20709939",
                "ReferenceType":"result",
                "ReferenceCitation":"Malm-Erjefält M, Bjørnsdottir I, Vanggaard J, Helleberg H, Larsen U, Oosterhuis B, van Lier JJ, Zdravkovic M, Olsen AK. Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro degradation by dipeptidyl peptidase IV and neutral endopeptidase. Drug Metab Dispos. 2010 Nov;38(11):1944-53. doi: 10.1124/dmd.110.034066. Epub 2010 Aug 13."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk",
                "SeeAlsoLinkURL":"http://novonordisk-trials.com"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000069450",
                "InterventionMeshTerm":"Liraglutide"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000054795",
                "InterventionAncestorTerm":"Incretins"
              },{
                "InterventionAncestorId":"D000006728",
                "InterventionAncestorTerm":"Hormones"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M419",
                "InterventionBrowseLeafName":"Liraglutide",
                "InterventionBrowseLeafAsFound":"Liraglutide",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8637",
                "InterventionBrowseLeafName":"Hypoglycemic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M26492",
                "InterventionBrowseLeafName":"Incretins",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Hypo",
                "InterventionBrowseBranchName":"Hypoglycemic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}