{ "FullStudy":{ "Rank":218231, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511029", "OrgStudyIdInfo":{ "OrgStudyId":"223HV102" }, "Organization":{ "OrgFullName":"Knopp Biosciences", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate)", "OfficialTitle":"A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy Volunteers" }, "StatusModule":{ "StatusVerifiedDate":"November 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 9, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 25, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Knopp Biosciences", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.", "DetailedDescription":"This is a Phase I, single-center, blinded (with respect to dexpramipexole administration), randomized, placebo- and active-controlled, 4-period crossover study in approximately 68 healthy volunteers. This thorough QT/QTc study will be conducted to formally evaluate the effect of dexpramipexole on QT prolongation." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Amyotrophic Lateral Sclerosis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"68", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Dexpramipexole", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Dexpramipexole" ] } },{ "ArmGroupLabel":"Dexpramipexole (placebo)", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Dexpramipexole Placebo" ] } },{ "ArmGroupLabel":"Moxifloxacin", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Moxifloxacin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Dexpramipexole", "InterventionDescription":"300 mg - Oral Tablets", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dexpramipexole" ] } },{ "InterventionType":"Drug", "InterventionName":"Dexpramipexole", "InterventionDescription":"600 mg Oral Tablets", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dexpramipexole" ] } },{ "InterventionType":"Drug", "InterventionName":"Dexpramipexole Placebo", "InterventionDescription":"Placebo - Oral Tablet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dexpramipexole (placebo)" ] } },{ "InterventionType":"Drug", "InterventionName":"Moxifloxacin", "InterventionDescription":"400 mg - Oral Tablet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Moxifloxacin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"To evaluate whether a single dose of dexpramipexole prolongs the QTC interval as measured by frequent ECG measurements (using Holter monitoring) of individually corrected QT intervals (QTcI)", "PrimaryOutcomeTimeFrame":"change from baseline" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Area Under Curve (AUC) of dexpramipexole", "SecondaryOutcomeTimeFrame":"pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 23 hours after dosing on Day 1 of each treatment period" },{ "SecondaryOutcomeMeasure":"Change in ECG measurements", "SecondaryOutcomeTimeFrame":"baseline and Day 7" },{ "SecondaryOutcomeMeasure":"Cmax of dexpramipexole", "SecondaryOutcomeTimeFrame":"pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 23 hours after dosing on Day 1 of each treatment period" },{ "SecondaryOutcomeMeasure":"Tmax of dexpramipexole", "SecondaryOutcomeTimeFrame":"pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 23 hours after dosing on Day 1 of each treatment period" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAged 18 to 60 years old inclusive on Day 1.\nSubjects who, in the opinion of the Investigator, are healthy as determined by pre study medical history, physical examination, and 12 lead ECG.\nMale subjects and female subjects of childbearing potential must practice effective contraception (per protocol specifications).\nNormal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmHg and a diastolic blood pressure of 50 to 90 mmHg.\n\nExclusion Criteria:\n\nHistory of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, Long QT Syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval), in the opinion of the Investigator.\nA prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval >450 ms before study treatment administration.\nClinically important abnormalities in resting ECG that may interfere with the interpretation of QTc interval changes at screening, check-in, or pre-dose on Day -1 of the first treatment period.\nOther medically significant illness.\nClinically significant abnormal laboratory values.\nPregnant women or women breastfeeding.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Overland Park", "LocationState":"Kansas", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077266", "InterventionMeshTerm":"Moxifloxacin" },{ "InterventionMeshId":"D000077487", "InterventionMeshTerm":"Pramipexole" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000059005", "InterventionAncestorTerm":"Topoisomerase II Inhibitors" },{ "InterventionAncestorId":"D000059003", "InterventionAncestorTerm":"Topoisomerase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000975", "InterventionAncestorTerm":"Antioxidants" },{ "InterventionAncestorId":"D000020011", "InterventionAncestorTerm":"Protective Agents" },{ "InterventionAncestorId":"D000000978", "InterventionAncestorTerm":"Antiparkinson Agents" },{ "InterventionAncestorId":"D000018726", "InterventionAncestorTerm":"Anti-Dyskinesia Agents" },{ "InterventionAncestorId":"D000018491", "InterventionAncestorTerm":"Dopamine Agonists" },{ "InterventionAncestorId":"D000015259", "InterventionAncestorTerm":"Dopamine Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1722", "InterventionBrowseLeafName":"Moxifloxacin", "InterventionBrowseLeafAsFound":"Moxifloxacin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1813", "InterventionBrowseLeafName":"Pramipexole", "InterventionBrowseLeafAsFound":"Dexpramipexole", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M140649", "InterventionBrowseLeafName":"Norgestimate, ethinyl estradiol drug combination", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2873", "InterventionBrowseLeafName":"Antioxidants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M20453", "InterventionBrowseLeafName":"Protective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2876", "InterventionBrowseLeafName":"Antiparkinson Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6056", "InterventionBrowseLeafName":"Dopamine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19179", "InterventionBrowseLeafName":"Dopamine Agonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16545", "InterventionBrowseLeafName":"Dopamine Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnDyAg", "InterventionBrowseBranchName":"Anti-Dyskinesia Agents" },{ "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" },{ "InterventionBrowseBranchAbbrev":"CaAg", "InterventionBrowseBranchName":"Cardiotonic Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000016472", "ConditionMeshTerm":"Motor Neuron Disease" },{ "ConditionMeshId":"D000000690", "ConditionMeshTerm":"Amyotrophic Lateral Sclerosis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000019636", "ConditionAncestorTerm":"Neurodegenerative Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000009468", "ConditionAncestorTerm":"Neuromuscular Diseases" },{ "ConditionAncestorId":"D000013118", "ConditionAncestorTerm":"Spinal Cord Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000057177", "ConditionAncestorTerm":"TDP-43 Proteinopathies" },{ "ConditionAncestorId":"D000057165", "ConditionAncestorTerm":"Proteostasis Deficiencies" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13998", "ConditionBrowseLeafName":"Sclerosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17462", "ConditionBrowseLeafName":"Motor Neuron Disease", "ConditionBrowseLeafAsFound":"Lateral Sclerosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2605", "ConditionBrowseLeafName":"Amyotrophic Lateral Sclerosis", "ConditionBrowseLeafAsFound":"Amyotrophic Lateral Sclerosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20142", "ConditionBrowseLeafName":"Neurodegenerative Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10994", "ConditionBrowseLeafName":"Neuromuscular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14498", "ConditionBrowseLeafName":"Spinal Cord Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M27346", "ConditionBrowseLeafName":"TDP-43 Proteinopathies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4726", "ConditionBrowseLeafName":"Primary Lateral Sclerosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T350", "ConditionBrowseLeafName":"Amyotrophic Lateral Sclerosis", "ConditionBrowseLeafAsFound":"Amyotrophic Lateral Sclerosis", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }