{
  "FullStudy":{
    "Rank":217961,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514578",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CP130-1001"
          },
          "Organization":{
            "OrgFullName":"Trevena Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males",
          "OfficialTitle":"A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TRV130A in Healthy Adult Males"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 23, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"August 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Trevena Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "safety",
              "tolerability",
              "TRV130A"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"74",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"TRV130A",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: TRV130A"
                  ]
                }
              },{
                "ArmGroupLabel":"Dextrose in Water",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Dextrose in Water"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"TRV130A",
                "InterventionDescription":"Intravenous infusion of 1 hour duration",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "TRV130A"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Dextrose in Water",
                "InterventionDescription":"Intravenous infusion of 1 hour duration",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Dextrose in Water"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of subjects with adverse events",
                "PrimaryOutcomeTimeFrame":"Baseline to 8 days after dose administration"
              },{
                "PrimaryOutcomeMeasure":"Area under the plasma concentration versus time curve of TRV130A",
                "PrimaryOutcomeTimeFrame":"Baseline to 24 hours after dose administration"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Effect of TRV130A on pain perception using cold pain test",
                "SecondaryOutcomeTimeFrame":"Baseline to 3 hours after dose administration"
              },{
                "SecondaryOutcomeMeasure":"Effect of TRV130A on pupil diameter",
                "SecondaryOutcomeTimeFrame":"Baseline to 3 hours after dose administration"
              },{
                "SecondaryOutcomeMeasure":"Effect of TRV130A on eye movements",
                "SecondaryOutcomeDescription":"Using saccadic eye movement measurement",
                "SecondaryOutcomeTimeFrame":"Baseline to 3 hours after dose administration"
              },{
                "SecondaryOutcomeMeasure":"Effect of TRV130A on sedation",
                "SecondaryOutcomeDescription":"Sedation evaluated by questionnaire",
                "SecondaryOutcomeTimeFrame":"Baseline to 3 hours after dose administration"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy adult male 19 - 50 years of age\nBody weight >/= 50 kg\nCapable of giving written informed consent\n\nExclusion Criteria:\n\nClinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study\nLaboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine\nMajor surgery within 4 weeks of screening",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"19 Years",
          "MaximumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"David G. Soergel, MD",
                "OverallOfficialAffiliation":"Trevena Inc.",
                "OverallOfficialRole":"Study Director"
              },{
                "OverallOfficialName":"Alan S. Marion, MD, PhD",
                "OverallOfficialAffiliation":"ICON Development Solutions",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"ICON Development Solutions",
                "LocationCity":"Omaha",
                "LocationState":"Nebraska",
                "LocationZip":"68154",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24122908",
                "ReferenceType":"derived",
                "ReferenceCitation":"Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28."
              },{
                "ReferencePMID":"23813302",
                "ReferenceType":"derived",
                "ReferenceCitation":"Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"ICON Development Solutions",
                "SeeAlsoLinkURL":"http://www.iconplc.com/study-volunteers/usa/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}