[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654274":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":71,"studyPopulation":71,"armGroups":83,"interventions":96,"overallOfficials":104,"centralContacts":108,"locations":114,"responsibleParty":128,"collaborators":71,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":71,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":71,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":71,"overallStatus":117,"whyStopped":71,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Novo Nordisk A\u002FS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":71},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Number of treatment emergent adverse events (TEAEs)","Measured as number of events.","From time of dosing (day 1) to day 7",{"measure":14,"description":11,"timeFrame":15},"Number of TEAEs","From time of dosing (day 1) to day 13",{"measure":17,"description":18,"timeFrame":19},"AUC0-t, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose","Measured as hour micromolar (h\\*μM).","From pre-dose (day 1 or day 10) to day 6 or day 15",{"measure":21,"description":22,"timeFrame":23},"Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces)","Measured as percentage (%) of dose.","From time of dosing (day 1) to no later than day 21",[25,29,32,35,39,40,41,45,49,51,55,57,60,63,66,69],{"measure":26,"description":27,"timeFrame":28},"AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose","Measured as h\\*μM.","From pre-dose (day 1) to day 7",{"measure":30,"description":31,"timeFrame":28},"Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose","Measured as micromolar (μM).",{"measure":33,"description":27,"timeFrame":34},"AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose","From pre-dose (day 7) to tau after last dose (day 8)",{"measure":36,"description":37,"timeFrame":38},"Cmax, MD; the maximum observed plasma concentration of NNC0705-0002 after last dose","Measured as μM.","From pre-dose (day 7) to day 13",{"measure":26,"description":27,"timeFrame":19},{"measure":30,"description":37,"timeFrame":19},{"measure":42,"description":43,"timeFrame":44},"Dose-normalised AUC0-∞, SD; the area under the NNC0705-0002 or radiolabelled NNC0705-0002-related material total radioactivity (TRA) plasma concentration-time curve from time 0 to infinity after a single dose divided by dose","Measured as hour micromolar per milligram (h\\*μM\u002Fmg).","From pre-dose (day 1) to day 17",{"measure":46,"description":47,"timeFrame":48},"Total amount of radiolabelled NNC0705-0002- related material excreted in urine","Measured as % of dose.","From pre-dose (day 1) to day 6",{"measure":50,"description":47,"timeFrame":48},"Total amount of radiolabelled NNC0705-0002- related material excreted in faeces",{"measure":52,"description":53,"timeFrame":54},"AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose","Measured as hundreds of nanomoles per litre (h\\*nmol\u002FL).","From pre-dose (day 1) to day 9",{"measure":14,"description":11,"timeFrame":56},"From time of dosing (day 1) to day 17",{"measure":52,"description":58,"timeFrame":59},"Measured as h\\*nmol\u002FL.","From pre-dose (day 1) to no later than day 21",{"measure":61,"description":62,"timeFrame":59},"Cmax,14C,SD: maximum observed plasma concentration of radiolabelled NNC0705-0002- related material (TRA) after a single dose","Measured as nanomole per litre (nmol\u002FL).",{"measure":64,"description":58,"timeFrame":65},"AUC0-∞,SD; area under the plasma concentration-time curve of NNC0705- 0002 from time 0 to infinity after a single dose","From pre-dose (day 1) to day 5",{"measure":67,"description":68,"timeFrame":65},"Cmax,SD: maximum observed plasma concentration of NNC0705-0002 after a single dose","Measured as nmol\u002FL.",{"measure":14,"description":11,"timeFrame":70},"From time of dosing (day 1) to day 23",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":78},"QUADRUPLE",[79,80,81,82],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[84,90],{"label":85,"type":86,"description":87,"interventionNames":88},"NNC0705-0002","EXPERIMENTAL","Participants will receive NNC0705-0002 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed\u002Ffasted conditions.",[89],"Drug: NNC0705-0002",{"label":91,"type":92,"description":93,"interventionNames":94},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo matched to NNC0705-0002 administered orally as a SAD, MAD, or under fed\u002Ffasted conditions.",[95],"Drug: Placebo",[97,101],{"type":98,"name":85,"description":99,"armGroupLabels":100,"otherNames":71},"DRUG","Participants will receive oral capsule of NNC0705-0002.",[85],{"type":98,"name":91,"description":102,"armGroupLabels":103,"otherNames":71},"Participants will receive oral capsule of placebo matched to NNC0705-0002.",[91],[105],{"name":106,"affiliation":5,"role":107},"Clinical Transparency (dept. 2834)","STUDY_DIRECTOR",[109],{"name":110,"role":111,"phone":112,"phoneExt":71,"email":113},"Novo Nordisk","CONTACT","(+1) 866-867-7178","clinicaltrials@novonordisk.com",[115],{"facility":116,"status":117,"city":118,"state":71,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":71},"ICON - location Groningen","RECRUITING","Groningen","9728 NZ","Netherlands","NL",{"type":123,"coordinates":124},"Point",[125,126],6.56667,53.21917,{"lat":126,"lon":125},{"type":129,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100654274","phase-1-a-study-to-see-how-safe-a-new-medicine-nnc0705-0002-is-in-healthy-people-100654274",false,"NCT07797855","A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People","A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Target Engagement, and Absorption, Metabolism and Excretion of NNC0705-0002 Following Single and Multiple Oral Administrations of NNC0705-0002 in Healthy Adults","Inclusion Criteria:\n\n* Men or women of non-childbearing potential.\n* Age 18-55 years (both inclusive) at the time of signing the informed consent.\n* Body mass index (BMI) between 18.5 to 29.9 kilogram per square metre (kg\u002Fm\\^2) (both inclusive) at screening.\n* Body weight: greater than or equal to (≥) 50.0 kg at screening.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.\n\n  * Alanine aminotransferase (ALT) greater than (\\>) upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) \\>ULN\n  * Total bilirubin (TBL) \\>ULN\n  * Creatinine \\>ULN\n  * International normalised ratio (INR) \\>ULN\n  * High-sensitivity C-reactive protein (hsCRP) greater than (\\>)5 milligram per liter (mg\u002FL) (males) and \\>8 mg\u002FL (females)\n* Use of prescription medicinal products or vaccines within 14 days before dosing and\u002For non-prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter acetaminophen\u002Fparacetamol and\u002For nonsteroidal anti-inflammatory drugs at their labelled doses for mild pain; vitamins at their labelled doses.",true,"ALL","18 Years","55 Years",{"count":142,"type":143},112,"ESTIMATED","INTERVENTIONAL",[146],"PHASE1","This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.",[149,150],"Healthy Volunteers","Cardiometabolic Diseases","2026-09-29",{"date":153,"type":154},"2026-09-30","ACTUAL",{"date":156,"type":154},"2026-09-02",{"date":158,"type":143},"2027-08-01",{"name":5,"class":6},1]