{ "FullStudy":{ "Rank":217685, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518166", "OrgStudyIdInfo":{ "OrgStudyId":"NN2211-1608" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2006-000175-15", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH", "OfficialTitle":"A Two-way Cross-over, Placebo-controlled Interaction Trial in Two Parts (in Healthy Subjects), Studying Liraglutide's Potential Influence on the Absorption Pharmacokinetics of Lisinopril, Atorvastatin, Griseofulvin and Digoxin, and Liraglutide's Potential Influence on Intragastric pH" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2007", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2007", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 21, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novo Nordisk A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®), griseofulvin and digoxin (Lanoxin®)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Healthy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"70", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Trial period A", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo", "Drug: atorvastatin", "Drug: lisinopril" ] } },{ "ArmGroupLabel":"Trial period B", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo", "Drug: griseofulvin", "Drug: digoxin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trial period A", "Trial period B" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trial period A", "Trial period B" ] } },{ "InterventionType":"Drug", "InterventionName":"atorvastatin", "InterventionDescription":"One single dose of 40 mg. Tablet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trial period A" ] } },{ "InterventionType":"Drug", "InterventionName":"lisinopril", "InterventionDescription":"One single dose of 20 mg. Tablet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trial period A" ] } },{ "InterventionType":"Drug", "InterventionName":"griseofulvin", "InterventionDescription":"One single dose of 500 mg. Tablet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trial period B" ] } },{ "InterventionType":"Drug", "InterventionName":"digoxin", "InterventionDescription":"One single dose of 1 mg. Tablet", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Trial period B" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Area under the curve of atorvastatin" },{ "PrimaryOutcomeMeasure":"Area under the curve of lisinopril" },{ "PrimaryOutcomeMeasure":"Area under the curve of griseofulvin" },{ "PrimaryOutcomeMeasure":"Area under the curve of digoxin" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Area under the curve of liraglutide" },{ "SecondaryOutcomeMeasure":"Cmax, maximum concentration" },{ "SecondaryOutcomeMeasure":"tmax, time to reach Cmax" },{ "SecondaryOutcomeMeasure":"Terminal elimination rate constant" },{ "SecondaryOutcomeMeasure":"Intragastric pH" },{ "SecondaryOutcomeMeasure":"Adverse events" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nFemale subjects if using adequate anti-contraception or is sterile\nBody Mass Index (BMI) of 18-30 kg/m^2 (both inclusive)\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\nWilling and capable to self-administer a subcutaneous injection\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\nBlood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min\nAny clinically significant abnormal ECG\nActive hepatitis B and/or active hepatitis C\nPositive HIV (human immunodeficiency virus) antibodies\nKnown or suspected allergy to trial product(s) or related products\nUse of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period\nHistory of alcoholism or drug abuse during the last 12 months\nSmoking of more than 10 cigarettes per day, or the equivalent for other tobacco products\nHabitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"55 Years", "StdAgeList":{ "StdAge":[ "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":"Uppsala", "LocationZip":"75323", "LocationCountry":"Sweden" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"26426736", "ReferenceType":"result", "ReferenceCitation":"Malm-Erjefält M, Ekblom M, Vouis J, Zdravkovic M, Lennernäs H. Effect on the Gastrointestinal Absorption of Drugs from Different Classes in the Biopharmaceutics Classification System, When Treating with Liraglutide. Mol Pharm. 2015 Nov 2;12(11):4166-73. doi: 10.1021/acs.molpharmaceut.5b00278. Epub 2015 Oct 12." } ] }, "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" },{ "InterventionMeshId":"D000006118", "InterventionMeshTerm":"Griseofulvin" },{ "InterventionMeshId":"D000004077", "InterventionMeshTerm":"Digoxin" },{ "InterventionMeshId":"D000017706", "InterventionMeshTerm":"Lisinopril" },{ "InterventionMeshId":"D000069059", "InterventionMeshTerm":"Atorvastatin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000924", "InterventionAncestorTerm":"Anticholesteremic Agents" },{ "InterventionAncestorId":"D000000960", "InterventionAncestorTerm":"Hypolipidemic Agents" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000057847", "InterventionAncestorTerm":"Lipid Regulating Agents" },{ "InterventionAncestorId":"D000019161", "InterventionAncestorTerm":"Hydroxymethylglutaryl-CoA Reductase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "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" },{ "InterventionAncestorId":"D000000889", "InterventionAncestorTerm":"Anti-Arrhythmia Agents" },{ "InterventionAncestorId":"D000002316", "InterventionAncestorTerm":"Cardiotonic Agents" },{ "InterventionAncestorId":"D000020011", "InterventionAncestorTerm":"Protective Agents" },{ "InterventionAncestorId":"D000000806", "InterventionAncestorTerm":"Angiotensin-Converting Enzyme Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" },{ "InterventionAncestorId":"D000000935", "InterventionAncestorTerm":"Antifungal Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M351", "InterventionBrowseLeafName":"Atorvastatin", "InterventionBrowseLeafAsFound":"Atorvastatin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M18507", "InterventionBrowseLeafName":"Lisinopril", "InterventionBrowseLeafAsFound":"Lisinopril", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M419", "InterventionBrowseLeafName":"Liraglutide", "InterventionBrowseLeafAsFound":"Liraglutide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M5848", "InterventionBrowseLeafName":"Digoxin", "InterventionBrowseLeafAsFound":"Digoxin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M7804", "InterventionBrowseLeafName":"Griseofulvin", "InterventionBrowseLeafAsFound":"Griseofulvin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2824", "InterventionBrowseLeafName":"Anticholesteremic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2859", "InterventionBrowseLeafName":"Hypolipidemic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2862", "InterventionBrowseLeafName":"Antimetabolites", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27470", "InterventionBrowseLeafName":"Lipid Regulating Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19739", "InterventionBrowseLeafName":"Hydroxymethylglutaryl-CoA Reductase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "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" },{ "InterventionBrowseLeafId":"M2794", "InterventionBrowseLeafName":"Anti-Arrhythmia Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4154", "InterventionBrowseLeafName":"Cardiotonic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M20453", "InterventionBrowseLeafName":"Protective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2715", "InterventionBrowseLeafName":"Angiotensin-Converting Enzyme Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2835", "InterventionBrowseLeafName":"Antifungal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4835", "InterventionBrowseLeafName":"Clotrimazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10379", "InterventionBrowseLeafName":"Miconazole", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Lipd", "InterventionBrowseBranchName":"Lipid Regulating Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"CaAg", "InterventionBrowseBranchName":"Cardiotonic Agents" },{ "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" } ] } }, "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" } ] } } } } } }