[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423772":3},{"organization":4,"armGroups":7,"interventions":49,"overallOfficials":84,"centralContacts":55,"locations":92,"responsibleParty":105,"collaborators":107,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":55,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":55,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":136,"whyStopped":55,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,18,22,26,30,37,41,45],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Treatment Sequence ABECD","EXPERIMENTAL","Participants will receive a single oral dose of Treatments A, B, E, C, and D in Treatment periods 1 to 5 on Day 1 of the study.",[13,14,15,16,17],"Drug: Treatment A","Drug: Treatment B","Drug: Treatment C","Drug: Treatment D","Drug: Treatment E",{"label":19,"type":10,"description":20,"interventionNames":21},"Group 1: Treatment Sequence BACED","Participants will receive a single oral dose of Treatments B, A, C, E, and D in Treatment periods 1 to 5 on Day 1 of the study.",[13,14,15,16,17],{"label":23,"type":10,"description":24,"interventionNames":25},"Group 1: Treatment Sequence CDBEA","Participants will receive a single oral dose of Treatments C, D, B, E, and A in Treatment periods 1 to 5 on Day 1 of the study.",[13,14,15,16,17],{"label":27,"type":10,"description":28,"interventionNames":29},"Group 1: Treatment Sequence EADBC","Participants will receive a single oral dose of Treatments E, A, D, B, and C in Treatment periods 1 to 5 on Day 1 of the study.",[13,14,15,16,17],{"label":31,"type":10,"description":32,"interventionNames":33},"Group 2: Treatment Sequence AFHG","Participants will receive a single oral dose of Treatments A, F, H, and G in Treatment periods 1 to 4 on Day 1 of the study.",[13,34,35,36],"Drug: Treatment F","Drug: Treatment G","Drug: Treatment H",{"label":38,"type":10,"description":39,"interventionNames":40},"Group 2: Treatment Sequence FGAH","Participants will receive a single oral dose of Treatments F, G, A, and H in Treatment periods 1 to 4 on Day 1 of the study.",[13,34,35,36],{"label":42,"type":10,"description":43,"interventionNames":44},"Group 2: Treatment Sequence GHFA","Participants will receive a single oral dose of Treatments G, H, F, and A in Treatment periods 1 to 4 on Day 1 of the study.",[13,34,35,36],{"label":46,"type":10,"description":47,"interventionNames":48},"Group 2: Treatment Sequence HAGF","Participants will receive a single oral dose of Treatments H, A, G, and F in Treatment periods 1 to 4 on Day 1 of the study.",[13,34,35,36],[50,56,60,64,68,72,76,80],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Treatment A","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.",[9,19,23,27,31,38,42,46],null,{"type":51,"name":57,"description":58,"armGroupLabels":59,"otherNames":55},"Treatment B","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.",[9,19,23,27],{"type":51,"name":61,"description":62,"armGroupLabels":63,"otherNames":55},"Treatment C","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition",[9,19,23,27],{"type":51,"name":65,"description":66,"armGroupLabels":67,"otherNames":55},"Treatment D","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.",[9,19,23,27],{"type":51,"name":69,"description":70,"armGroupLabels":71,"otherNames":55},"Treatment E","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.",[9,19,23,27],{"type":51,"name":73,"description":74,"armGroupLabels":75,"otherNames":55},"Treatment F","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.",[31,38,42,46],{"type":51,"name":77,"description":78,"armGroupLabels":79,"otherNames":55},"Treatment G","Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.",[31,38,42,46],{"type":51,"name":81,"description":82,"armGroupLabels":83,"otherNames":55},"Treatment H","Participants will receive oral dose of dapagliflozin capsule in fasted condition.",[31,38,42,46],[85,89],{"name":86,"affiliation":87,"role":88},"Ozan Dursun","Parexel Early Phase Clinical Unit Berlin Campus DRK Kliniken Berlin Westend, Haus 31 Spandauer Damm 130 14050 Berlin Germany","PRINCIPAL_INVESTIGATOR",{"name":90,"affiliation":91,"role":88},"Alen Jambrecina","CTC North GmbH & Co. KG Martinistrasse 64 20251 Hamburg Germany",[93],{"facility":94,"status":55,"city":95,"state":55,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":55},"Research Site","Berlin","14050","Germany","DE",{"type":100,"coordinates":101},"Point",[102,103],13.41053,52.52437,{"lat":103,"lon":102},{"type":106,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[108],{"name":109,"class":6},"Parexel","100423772","phase-1-study-to-assess-the-bioavailability-of-different-formulations-of-azd9977-and-dapagliflozin-and-influence-of-food-in-selected-formulations-in-healthy-volunteers-100423772",false,"NCT04798222","Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers","An Open-label, Randomized, Parallel Group, Four\u002FFive Period, Eight Treatment Cross-over, Single Oral Dose Study to Assess the Relative Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy participants of non-childbearing potential with suitable veins for cannulation or repeated venipuncture at screening\n* Females must have a negative pregnancy test at the screening Visit and a negative urine pregnancy test at admission to the study center, must not be lactating and must be of non childbearing potential\n* Have a body mass index between 18 and 29.9 kg\u002Fm\\^2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at screening\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the subject's ability to participate in the study\n* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs\n* Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).\n* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening, as judged by the Investigator\n* Any clinically significant abnormal findings in vital signs, and 12-lead electrocardiogram as judged by the Investigator\n* Any positive result on screening for serum hepatitis B surface antigen or anti-hemoglobin antibody, hepatitis C antibody, and human immunodeficiency virus antibody\n* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months (or 5 half lives, whichever is longer) of the first administration of IMP in this study\n* Plasma donation within 1 month of screening or any blood donation\u002Floss more than 500 mL during the 3 months prior to screening\n* History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977 or dapagliflozin\n* Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening\n* Participant has a positive test result for Severe acute respiratory syndrome coronavirus 2 reverse transcriptase polymerase chain reaction at admission\n* Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP\n* Use of any prescribed or non prescribed medication including antacids, analgesics, hormone replacement therapy, herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life\n* Participants who have previously received AZD9977 or dapagliflozin\n* Judgment by the Investigators that the participant should not participate in the study if they have any ongoing or recent minor medical complaints\n* Participants who cannot communicate reliably with the Investigator and\u002For is not able to read, speak and understand the German language\n* Participant has clinical signs and symptoms consistent with corona virus disease 2019 (COVID-19), or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on first admission\n* History of severe COVID-19 infection (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated) as judged by the Investigator",true,"ALL","18 Years","50 Years",{"count":122,"type":123},20,"ACTUAL","INTERVENTIONAL",[126],"PHASE1","The primary purpose of the study is to evaluate relative bioavailability of AZD9977 and dapagliflozin and compare the plasma concentration time profiles after dosing with different capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin, the AZD9977 capsule, and dapagliflozin tablet under fasted conditions.",[129],"Heart Failure",[131,132,133,134,135],"Bioavailability","Oral selective mineralocorticoid receptor modulator","Pharmacokinetics","Dapagliflozin","AZD9977","COMPLETED","2021-09-08",{"date":139,"type":123},"2021-09-09",{"date":141,"type":123},"2021-06-29",{"date":143,"type":123},"2021-09-03",{"name":5,"class":6},1]