{ "FullStudy":{ "Rank":217967, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514500", "OrgStudyIdInfo":{ "OrgStudyId":"NN8640-3915" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"U1111-1119-0539", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"WHO" },{ "SecondaryId":"2011-000146-38", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects", "OfficialTitle":"First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects" }, "StatusModule":{ "StatusVerifiedDate":"May 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 16, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 18, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 18, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 23, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 25, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novo Nordisk A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Growth Hormone Disorder", "Adult Growth Hormone Deficiency", "Growth Hormone Deficiency in Children", "Healthy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"105", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Single dose (SD)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: somapacitan", "Drug: placebo (somapacitan)" ] } },{ "ArmGroupLabel":"Multiple dose (MD)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: somapacitan", "Drug: placebo (somapacitan)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"somapacitan", "InterventionDescription":"Administered s.c. (subcutaneously, under the skin)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Multiple dose (MD)", "Single dose (SD)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "NNC0195-0092" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo (somapacitan)", "InterventionDescription":"Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Multiple dose (MD)", "Single dose (SD)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Incidence of adverse events (Single Dose)", "PrimaryOutcomeTimeFrame":"From first administration of trial product and up until day 40" },{ "PrimaryOutcomeMeasure":"Incidence of adverse events (Multiple Dose)", "PrimaryOutcomeTimeFrame":"From first administration of trial product and up until day 49" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Area under the NNC0195-0092 (somapacitan) serum concentration-time curve", "SecondaryOutcomeTimeFrame":"From 0 to 168 hours" },{ "SecondaryOutcomeMeasure":"Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)", "SecondaryOutcomeTimeFrame":"From 0-240 hours" },{ "SecondaryOutcomeMeasure":"Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)", "SecondaryOutcomeTimeFrame":"up to day 40" },{ "SecondaryOutcomeMeasure":"Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)", "SecondaryOutcomeTimeFrame":"up to day 40" },{ "SecondaryOutcomeMeasure":"Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve", "SecondaryOutcomeTimeFrame":"From 0-168 hours" },{ "SecondaryOutcomeMeasure":"Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)", "SecondaryOutcomeTimeFrame":"From 0-240 hours" },{ "SecondaryOutcomeMeasure":"Maximum serum concentration (Cmax) for IGF-I", "SecondaryOutcomeTimeFrame":"up to day 40" },{ "SecondaryOutcomeMeasure":"Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve", "SecondaryOutcomeTimeFrame":"From 0-168 hours" },{ "SecondaryOutcomeMeasure":"Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)", "SecondaryOutcomeTimeFrame":"From 0-240 hours" },{ "SecondaryOutcomeMeasure":"Maximum serum concentration (Cmax) for IGFBP-3", "SecondaryOutcomeTimeFrame":"up to day 40" },{ "SecondaryOutcomeMeasure":"Number of injection site reactions", "SecondaryOutcomeTimeFrame":"From first administration of trial product and up until day 40 (SD part)" },{ "SecondaryOutcomeMeasure":"Number of injection site reactions", "SecondaryOutcomeTimeFrame":"From first administration of trial product and up until day 49 (MD part)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy, non-smoking male subjects\nBMI (body mass index) between 18.0 and 28.0 kg/m^2, both incl.\nBody weight 50 to 100 kg, both incl.\n\nExclusion Criteria:\n\nStrenuous exercise within 4 days prior to dosing\nReceipt of any investigational medicinal product within 3 months prior to randomisation", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"20 Years", "MaximumAge":"45 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":"Neuss", "LocationZip":"41460", "LocationCountry":"Germany" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"29671202", "ReferenceType":"derived", "ReferenceCitation":"Juul RV, Rasmussen MH, Agersø H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5." },{ "ReferencePMID":"25013997", "ReferenceType":"derived", "ReferenceCitation":"Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000004393", "ConditionMeshTerm":"Dwarfism, Pituitary" },{ "ConditionMeshId":"D000004700", "ConditionMeshTerm":"Endocrine System Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004392", "ConditionAncestorTerm":"Dwarfism" },{ "ConditionAncestorId":"D000001848", "ConditionAncestorTerm":"Bone Diseases, Developmental" },{ "ConditionAncestorId":"D000001847", "ConditionAncestorTerm":"Bone Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000001849", "ConditionAncestorTerm":"Bone Diseases, Endocrine" },{ "ConditionAncestorId":"D000007018", "ConditionAncestorTerm":"Hypopituitarism" },{ "ConditionAncestorId":"D000010900", "ConditionAncestorTerm":"Pituitary Diseases" },{ "ConditionAncestorId":"D000007027", "ConditionAncestorTerm":"Hypothalamic Diseases" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12374", "ConditionBrowseLeafName":"Pituitary Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6150", "ConditionBrowseLeafName":"Dwarfism, Pituitary", "ConditionBrowseLeafAsFound":"Growth Hormone Deficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6149", "ConditionBrowseLeafName":"Dwarfism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafAsFound":"Hormone Deficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3708", "ConditionBrowseLeafName":"Bone Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3709", "ConditionBrowseLeafName":"Bone Diseases, Developmental", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3710", "ConditionBrowseLeafName":"Bone Diseases, Endocrine", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8651", "ConditionBrowseLeafName":"Hypopituitarism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8660", "ConditionBrowseLeafName":"Hypothalamic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2645", "ConditionBrowseLeafName":"Growth Hormone Deficiency", "ConditionBrowseLeafAsFound":"Growth Hormone Deficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T3136", "ConditionBrowseLeafName":"Isolated Growth Hormone Deficiency", "ConditionBrowseLeafAsFound":"Growth Hormone Deficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T2966", "ConditionBrowseLeafName":"Hypopituitarism", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }