{
  "FullStudy":{
    "Rank":218240,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510899",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BP25261"
          },
          "Organization":{
            "OrgFullName":"Hoffmann-La Roche",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838",
          "OfficialTitle":"A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 1, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 2, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hoffmann-La Roche",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy Volunteer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Healthy Subjects Arm",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: RO4917838"
                  ]
                }
              },{
                "ArmGroupLabel":"Renal Impaired Subjects Arm",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: RO4917838"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"RO4917838",
                "InterventionDescription":"Single dose of RO4917838",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Renal Impaired Subjects Arm"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"RO4917838",
                "InterventionDescription":"Single dose of RO4917838",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Healthy Subjects Arm"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Pharmacokinetics: Area under concentration time curve of RO4917838",
                "PrimaryOutcomeTimeFrame":"Days 1-16"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Safety: Incidence of adverse events",
                "SecondaryOutcomeTimeFrame":"9 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nGeneral criteria\n\nBody mass index (BMI) between 18 and 32 kg/m2\n\nCriteria applying to renal impaired subjects\n\nAdult subjects, 18-65 years of age\nPart 1: Subjects with end stage renal disease (ESRD), not on dialysis\nPart 2: Subjects with severe, moderate or mild renal impairment\nStable renal function\n\nCriteria applying to healthy subjects\n\nAdult subjects, 18-70 years of age\n\nExclusion Criteria:\n\nGeneral criteria\n\nAny condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk\nAny condition which could relapse during or immediately after the study\nHistory of alcohol or drug abuse\n\nCriteria applying to renal impaired subjects\n\nEvidence of unstable clinically significant disease other than renal impairment\nClinically significant liver disease\nAny other major illness (with the exception of renal impairment) within 4 weeks prior to study start\n\nCriteria applying to healthy subjects\n\nHistory of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Clinical Trials",
                "OverallOfficialAffiliation":"Hoffmann-La Roche",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Rennes",
                "LocationZip":"35042",
                "LocationCountry":"France"
              },{
                "LocationCity":"Moscow",
                "LocationZip":"117192",
                "LocationCountry":"Russian Federation"
              },{
                "LocationCity":"Moscow",
                "LocationZip":"117292",
                "LocationCountry":"Russian Federation"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000051437",
                "ConditionMeshTerm":"Renal Insufficiency"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000007674",
                "ConditionAncestorTerm":"Kidney Diseases"
              },{
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25305",
                "ConditionBrowseLeafName":"Renal Insufficiency",
                "ConditionBrowseLeafAsFound":"Renal Impairment",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}