[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646831":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":38,"armGroups":46,"interventions":58,"overallOfficials":38,"centralContacts":71,"locations":77,"responsibleParty":91,"collaborators":38,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":38,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":38,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":80,"whyStopped":38,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":38},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Area under concentration time curve from time 0 to infinity (AUCinf)","To assess the effect of itraconazole on the PK (AUCinf) of AZD4144","Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16",{"measure":14,"description":15,"timeFrame":12},"Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)","To assess the effect of itraconazole on the PK (AUClast) of AZD4144",{"measure":17,"description":18,"timeFrame":12},"Maximum observed drug concentration (Cmax)","To assess the effect of itraconazole on the PK (Cmax) of AZD4144",[20,23,26,29,32,35],{"measure":21,"description":22,"timeFrame":12},"Total body clearance (CL)","To describe the PK (CL) of AZD4144 when administered alone, and in combination with itraconazole",{"measure":24,"description":25,"timeFrame":12},"Apparent total body clearance (CL\u002FF)","To describe the PK (CL\u002FF) of AZD4144 when administered alone, and in combination with itraconazole",{"measure":27,"description":28,"timeFrame":12},"Volume of distribution during the terminal phase (Vz)","To describe the PK (Vz) of AZD4144 when administered alone, and in combination with itraconazole",{"measure":30,"description":31,"timeFrame":12},"Apparent volume of distribution based on the terminal phase (Vz\u002FF)","To describe the PK (Vz\u002FF) of AZD4144 when administered alone, and in combination with itraconazole",{"measure":33,"description":34,"timeFrame":12},"Terminal elimination half life (t½λz)","To describe the PK (t½λz) of AZD4144 when administered alone, and in combination with itraconazole",{"measure":36,"description":37,"timeFrame":12},"Time to reach maximum observed concentration (tmax)","To describe the PK (tmax) of AZD4144 when administered alone, and in combination with itraconazole",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE","This is an open-label, randomised, two arm, 3 period, fixed sequence study in healthy participants.\n\nThe study will include two parallel, independent arms with one arm evaluating oral administration of AZD4144 and the other evaluating AZD4144 administered as an intravenous (IV) infusion.\n\nEach study arm will comprise of:\n\n1. A screening period of up to 28 days.\n2. Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole.\n3. A final follow-up visit.",[47,54],{"label":48,"type":49,"description":50,"interventionNames":51},"Arm 1: Oral AZD4144","EXPERIMENTAL","In Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.",[52,53],"Drug: AZD4144","Drug: Itraconazole",{"label":55,"type":49,"description":56,"interventionNames":57},"Arm 2: IV Infusion AZD4144","In Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.",[52,53],[59,64,67],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":38},"DRUG","AZD4144","AZD4144 will be administered orally.",[48],{"type":60,"name":61,"description":65,"armGroupLabels":66,"otherNames":38},"AZD4144 will be administered as an IV infusion.",[55],{"type":60,"name":68,"description":69,"armGroupLabels":70,"otherNames":38},"Itraconazole","Itraconazole will be administered orally.",[48,55],[72],{"name":73,"role":74,"phone":75,"phoneExt":38,"email":76},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[78],{"facility":79,"status":80,"city":81,"state":38,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":38},"Research Site","RECRUITING","Harrow","HA1 3UJ","United Kingdom","UK",{"type":86,"coordinates":87},"Point",[88,89],-0.33208,51.57835,{"lat":89,"lon":88},{"type":92,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100646831","phase-1-investigating-the-effect-of-itraconazole-on-the-pharmacokinetics-of-azd4144-in-healthy-participants-100646831",false,"NCT07685600","Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants","An Open-label, Randomised, Two Arm, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD4144 When Administered Alone and in Combination With Itraconazole","Inclusion Criteria:\n\n1. Healthy male and\u002For female participants with suitable veins for cannulation or repeated venipuncture.\n2. Body mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive, and body weight of at least 50 kg.\n3. Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.\n4. Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.\n\nExclusion Criteria:\n\n1. Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.\n2. History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.\n3. Any clinically important illness, medical\u002Fsurgical procedure, or trauma.\n4. Active systemic bacterial, viral, or fungal infection.\n5. Clinically significant serious active or chronic infections.\n6. Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.\n7. Concomitant immunosuppressive, steroid treatment.\n8. Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.\n9. Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.\n10. Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).",true,"ALL","18 Years","55 Years",{"count":105,"type":106},32,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.",[112],"Healthy",[114,115,116,117],"Pharmacokinetics","Cardiorenal diseases","Cryopyrin","Drug-drug interaction","2026-08-21",{"date":120,"type":121},"2026-08-24","ACTUAL",{"date":123,"type":121},"2026-07-30",{"date":125,"type":106},"2026-10-29",{"name":5,"class":6},1]