[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472931":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":32,"locations":49,"responsibleParty":72,"collaborators":32,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":32,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":32,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (midazolam and omeprazole)","EXPERIMENTAL","Participants will receive single oral doses of midazolam and omeprazole together (Day 1 of Treatment Periods 1 and 3) and repeated doses of AZD9833 (Days 1 to 5 of Treatment Period 2 and Day 1 of Treatment Period 3)",[13,14,15],"Drug: AZD9833","Drug: Midazolam","Drug: Omeprazole",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm B (Dabigatran etexilate)","Participants will receive single oral doses of dabigatran etexilate (Day 1 of Treatment Periods 1 and 2) and single oral dose of AZD9833 (Day 1 of Treatment Period 2)",[13,20],"Drug: Dabigatran Etexilate",{"label":22,"type":10,"description":23,"interventionNames":24},"Arm C (Celecoxib)","Participants will receive single oral doses of celecoxib (Day 1 of Treatment Periods 1 and 3) and repeated oral doses of AZD9833 (Days 1 to 5 of Treatment Period 2 and Day 1 of Treatment Period 3)",[13,25],"Drug: Celecoxib",[27,33,37,41,45],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","AZD9833","AZD9833 tablets will be administered orally once daily on Days 1 - Day 5 (Treatment Period 2) and Day 1 (Treatment Period 3) for participants recruited to Arms A and C and Day 1 for those in Arm B",[9,17,22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Midazolam","Midazolam will be administered orally as a syrup once on Day 1 of Treatment Periods 1 and 3; administered together with Omeprazole",[9],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Omeprazole","An Omeprazole capsule will be administered once on Day 1 of Treatment Periods 1 and 3; administered together with Midazolam",[9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Dabigatran Etexilate","A Dabigatran Etexilate capsule will be administered once on Day 1 of Treatment Periods 1 and 2",[17],{"type":28,"name":46,"description":47,"armGroupLabels":48,"otherNames":32},"Celecoxib","A Celecoxib capsule will be administered once on Day 1 of Treatment Periods 1 and 3",[22],[50,63],{"facility":51,"status":32,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":32},"Research Site","Long Beach","California","90806","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-118.18923,33.76696,{"lat":61,"lon":60},{"facility":51,"status":32,"city":64,"state":65,"zip":66,"country":55,"countryCode":56,"cosmosGeoPoint":67,"geoPoint":71,"contacts":32},"Berlin","New Jersey","08009",{"type":58,"coordinates":68},[69,70],-74.92905,39.79123,{"lat":70,"lon":69},{"type":73,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100472931","phase-1-study-to-assess-the-effect-of-co-administration-of-azd9833-on-the-pharmacokinetics-of-midazolam-of-omeprazole-of-celecoxib-and-of-dabigatran-etexilate-in-healthy-postmenopausal-female-volunteers-100472931",false,"NCT05438303","Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers","A Phase 1, Multi-center, Open-label, 3-arm, Fixed Sequence Study to Assess the Effect of Co-administration of AZD9833 on the Pharmacokinetics of Midazolam (CYP3A4\u002F5 Substrate), of Omeprazole (CYP2C19 Substrate), of Celecoxib (CYP2C9 Substrate) and of Dabigatran Etexilate (P-gp Transporter Substrate) in Healthy Postmenopausal Female Volunteers","Inclusion Criteria:\n\n* Healthy postmenopausal female participants aged 50 to 70 years with suitable veins for cannulation or repeated venipuncture.\n* Participants must be postmenopausal by fulfilling the following criterion:\n* Have a Body mass index (BMI) between 19 and 35 kg\u002Fm\\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive as measured at screening.\n* Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) during study, and for 2 weeks after last administration of IMP.\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder as described by the Investigator.\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* Use of systemic estrogen-containing hormone replacement therapy within 6 months prior to first dose in the study.\n* Have taken any proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, pantoprazole, etc.) within 14 days of beginning study treatment (ie, first administration of omeprazole in Arm A.\n* Have taken any drug with enzyme-inducing properties such as St John's Wort within 3 weeks of screening.\n* Presence of any contraindication to the probe substrates omeprazole, midazolam, dabigatran or celecoxib per the United States Package Insert.\n* Any of the following signs or confirmation of COVID-19 infection:\n* Subject has a positive RT-PCR test for SARS-CoV-2 prior to randomization.\n* Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or at randomization.\n* Subject has been previously hospitalized with COVID-19 infection within the last 12 months.",true,"FEMALE","50 Years","70 Years",{"count":86,"type":87},59,"ACTUAL","INTERVENTIONAL",[90],"PHASE1","This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites",[93],"Healthy Volunteers",[95,34,38,96,46,97,98],"Drug-Drug interaction","Dabigatran etexilate","Postmenopausal","Breast Cancer","COMPLETED","2023-01-11",{"date":102,"type":87},"2023-01-12",{"date":104,"type":87},"2022-06-13",{"date":106,"type":87},"2022-12-13",{"name":5,"class":6},2]