{
  "FullStudy":{
    "Rank":217581,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519531",
          "OrgStudyIdInfo":{
            "OrgStudyId":"VIA-3196-02"
          },
          "Organization":{
            "OrgFullName":"Madrigal Pharmaceuticals, Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy Subjects",
          "OfficialTitle":"A Randomized, Double-blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 24, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 4, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 6, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Madrigal Pharmaceuticals, Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Drug Safety"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"48",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"VIA-3196",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: VIA-3196"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Multiple, ascending dosing groups (cohorts) will be evaluated.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"VIA-3196",
                "InterventionDescription":"Oral, daily dosing for 14 days",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "VIA-3196"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of Adverse Events as a measure of safety and tolerability of VIA-3196",
                "PrimaryOutcomeDescription":"Evaluation will start from predose (Day -1) until the follow-up visit (Day 21)",
                "PrimaryOutcomeTimeFrame":"up to 22 days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Plasma concentration of VIA-3196",
                "SecondaryOutcomeDescription":"Assessed without food",
                "SecondaryOutcomeTimeFrame":"0 to 24 hours on Day 1 and Day 14"
              },{
                "SecondaryOutcomeMeasure":"Lipid level changes following administration of VIA-3196",
                "SecondaryOutcomeTimeFrame":"Day 1 to 14"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nThe subject must be willing and able to provide written informed consent.\nHealthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive).\nIf female, the subject is of non-child bearing potential (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [>12 consecutive months without menses]). Verify by FSH at screening as appropriate.\nBody weight > 50 kg and BMI between 18 and 30 kg/m2 (inclusive).\nLDL cholesterol ≥ 110mg/dL.\n\nExclusion Criteria:\n\nHistory of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed once at the discretion of the Investigator. - History of unexplained syncope.\nHistory of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening.\nPositive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.\nAbnormal screening ECG: including machine-read QTc >450 msec (confirmed by manual over read), QRS >110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.\nHistory of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing) unless deemed not clinically significant by the Investigator.\nHistory of sensitivity to thyroid medication.\nHistory of asthma, or intolerance to beta-blockers.\nUse of acetaminophen within 7 days before dosing and throughout the study.\nHistory of regular use of tobacco or nicotine containing products within the past 6 months.\nPositive urine drug screen or alcohol test at screening or Day -1.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Rebecca Taub, MD",
                "OverallOfficialAffiliation":"Madrigal Pharmaceuticals",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"PRACS Institute (formerly Cetero Research)",
                "LocationCity":"Fargo",
                "LocationState":"North Dakota",
                "LocationZip":"58104",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}