[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588556":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":35,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: AZD5004 + Itraconazole","EXPERIMENTAL","Participants will receive oral dose of AZD5004 on Period 1, followed by Itraconazole capsule orally in Period 2, and then will receive oral dose of AZD5004 combination with Itraconazole capsule in Period 3.",[13,14],"Drug: AZD5004","Drug: Itraconazole",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B: Ethinyl Estradiol\u002F Levonorgestrel (EE\u002FLNG) + AZD5004","Participants will receive one tablet of combined 0.03\u002F0.15 mg EE\u002FLNG and AZD5004 orally.",[13,19],"Drug: EE\u002FLNG",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","AZD5004","AZD50004 is administered orally as a tablet.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Itraconazole","Itraconazole is administered orally as a capsule.",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"EE\u002FLNG","EE\u002FLNG is administered orally in the form of tablet.",[16],[36,49],{"facility":37,"status":26,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Research Site","Baltimore","Maryland","21225","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-76.61219,39.29038,{"lat":47,"lon":46},{"facility":37,"status":26,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":26},"Berlin","14050","Germany","DE",{"type":44,"coordinates":55},[56,57],13.41053,52.52437,{"lat":57,"lon":56},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":63,"class":6},"Parexel","100588556","phase-1-a-study-to-investigate-the-impact-of-multiple-doses-of-itraconazole-on-azd5004-in-healthy-participants-and-multiple-doses-of-azd5004-on-combined-oral-ethinyl-oestradiol-and-levonorgestrel-in-healthy-female-participants-100588556",false,"NCT06942936","A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants","An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants","Main Inclusion Criteria:\n\nPart A -\n\n* Suitable veins for cannulation or repeated venipuncture.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\n* Females of childbearing potential must not be lactating, must agree to use approved method of contraceptive.\n* Sexually active fertile male participants with female partners of childbearing potential must adhere to the approved contraception methods.\n* Have a Body Mass Index (BMI) between ≥ 18.5 kg\u002Fm2 and ≤ 35 kg\u002Fm2 (at the time of screening) and weigh at least 50 kg.\n\nPart B -\n\n* Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:\n\n  1. Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels (\\> 40 mIU\u002FmL).\n  2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.\n* Have a BMI between ≥ 23 kg\u002Fm2 and ≤ 30 kg\u002Fm2 and weigh at least 55 kg.\n\nMain Exclusion Criteria:\n\nPart A and Part B-\n\n* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study.\n* History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase\u002Fpancreatic amylase at screening.\n* History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* Abnormal laboratory values, hepatic disease, Human Immunodeficiency Virus (HIV) positive, abnormal vital signs, abnormalities in rhythm, uncontrolled thyroid disease.\n* Known smoker, history of alcohol, drug abuse or caffeine intake.\n* Use of prescribed or unsubscribed medication within 3 months prior to screening.\n* History of psychosis, bipolar disorder, major depressive disorder.\n* Vulnerable participants, e.g., kept in detention, protected adults under guardianship.",true,"ALL","18 Years","70 Years",{"count":76,"type":77},51,"ACTUAL","INTERVENTIONAL",[80],"PHASE1","The purpose of this study is to assess the impact of multiple doses of itraconazole on the pharmacokinetics (PK) of AZD5004 in healthy participants (Part A), and to assess the impact of multiple doses of AZD5004 on the PK of Combined Oral Contraceptives (COCs) in healthy female participants (Part B).",[83],"Healthy Participants",[85,86],"Obesity","Type 2 Diabetes","COMPLETED","2026-02-02",{"date":90,"type":77},"2026-02-03",{"date":92,"type":77},"2025-05-28",{"date":94,"type":77},"2026-01-28",{"name":5,"class":6},2]