[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653067":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":71,"studyPopulation":62,"armGroups":72,"interventions":91,"overallOfficials":62,"centralContacts":97,"locations":103,"responsibleParty":143,"collaborators":62,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":62,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":62,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":170,"whyStopped":62,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":62},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"PK parameters AUCinf","area under the concentration-time curve from zero to infinity","Day 0 through Day 7 or 9",{"measure":14,"description":15,"timeFrame":12},"PK parameter AUClast","area under the concentration-time curve from zero to the last measurable concentration",{"measure":17,"description":18,"timeFrame":19},"PK parameters AUC(0-144)","area under the curve from time zero to time 144hours post dose","Day 0 through Day 7",{"measure":21,"description":22,"timeFrame":12},"PK parameter Cmax","maximum observed plasma concentration",[24,27,30,33,36,39,43,46,49,52,55,59],{"measure":25,"description":26,"timeFrame":12},"PK parameters tmax","time to reach maximum observed plasma concentration",{"measure":28,"description":29,"timeFrame":12},"PK Parameters t1\u002F2λz","half-life associated with terminal slope (λz)",{"measure":31,"description":32,"timeFrame":12},"PK Parameters CL\u002FF","apparent total body clearance of drug from plasma after extravascular administration",{"measure":34,"description":35,"timeFrame":12},"PK Parameters Vz\u002FF","apparent volume of distribution during the terminal phase after extravascular administration.",{"measure":37,"description":38,"timeFrame":12},"PK Parameters CLNR\u002FF","non-renal clearance of drug from plasma",{"measure":40,"description":41,"timeFrame":42},"PK parameters CLR from urine concentrations","renal clearance from urine concentration","Day 0 through Day 3",{"measure":44,"description":45,"timeFrame":42},"PK parameters Ae determined from urine concentration","amount of unchanged drug excreted into the urine",{"measure":47,"description":48,"timeFrame":42},"PK parameters fe determined from urine concentration","Percentage of unchanged drug excreted into the urine",{"measure":50,"description":51,"timeFrame":12},"PK Parameters tlast","time of last quantifiable concentration",{"measure":53,"description":54,"timeFrame":12},"PK Parameters λz","terminal elimination rate constant",{"measure":56,"description":57,"timeFrame":58},"PK Parameters AUC(0-24)","area under the plasma concentration-time curve from time 0 to 24 hours postdose","Day 0 through Day 1",{"measure":60,"description":61,"timeFrame":42},"PK Parameters AUC(0-72)","area under the plasma concentration-time curve from time 0 to 72 hours postdose",null,{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":67,"observationalModel":62,"timePerspective":62,"maskingInfo":68},"NON_RANDOMIZED","PARALLEL","Participants will be enrolled into the following groups based on their Child-Pugh classification score as determined by a local laboratory at screening:\n\nGroup 1: Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 or 6).\n\nGroup 2: Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9).\n\nGroup 3: Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15).\n\nGroup 4: Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups.","TREATMENT",{"masking":69,"maskingDescription":70,"whoMasked":62},"NONE","No masking","This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.\n\nApproximately 60 participants are planned to be screened to achieve up to 30 evaluable participants. For each of the 3 hepatic impairment groups, 6 participants are planned to complete the study. Initially, 6 participants with normal hepatic function will be recruited, matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment. Additional participants with normal hepatic function, up to a total of 12, may be included if needed to meet the matching criteria.",[73,79,83,87],{"label":74,"type":75,"description":76,"interventionNames":77},"Group 1","EXPERIMENTAL","Participants with mild hepatic impairment (CP Class A, score of 5 or 6)",[78],"Drug: AZD4144",{"label":80,"type":75,"description":81,"interventionNames":82},"Group 2","Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).",[78],{"label":84,"type":75,"description":85,"interventionNames":86},"Group 3","Participants with severe hepatic impairment (CP Class C, score of 10 to 15).",[78],{"label":88,"type":75,"description":89,"interventionNames":90},"Group 4","Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups",[78],[92],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":62},"DRUG","AZD4144","Single oral dose of AZD4144 in participants from all groups",[74,80,84,88],[98],{"name":99,"role":100,"phone":101,"phoneExt":62,"email":102},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[104,117,126,134],{"facility":105,"status":62,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":62},"Research Site","Mesa","Arizona","85210","United States","US",{"type":112,"coordinates":113},"Point",[114,115],-111.82264,33.42227,{"lat":115,"lon":114},{"facility":105,"status":62,"city":118,"state":119,"zip":120,"country":109,"countryCode":110,"cosmosGeoPoint":121,"geoPoint":125,"contacts":62},"Miami Lakes","Florida","33014",{"type":112,"coordinates":122},[123,124],-80.30866,25.90871,{"lat":124,"lon":123},{"facility":105,"status":62,"city":127,"state":119,"zip":128,"country":109,"countryCode":110,"cosmosGeoPoint":129,"geoPoint":133,"contacts":62},"Orlando","32809",{"type":112,"coordinates":130},[131,132],-81.37924,28.53834,{"lat":132,"lon":131},{"facility":105,"status":62,"city":135,"state":136,"zip":137,"country":109,"countryCode":110,"cosmosGeoPoint":138,"geoPoint":142,"contacts":62},"Austin","Texas","78757",{"type":112,"coordinates":139},[140,141],-97.74306,30.26715,{"lat":141,"lon":140},{"type":144,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100653067","phase-1-a-phase-i-study-to-investigate-the-effect-of-hepatic-impairment-on-the-pharmacokinetics-safety-and-tolerability-of-azd4144-100653067",false,"NCT07783308","A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144","A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144","Inclusion Criteria:\n\nHealthy Matched Control Participants Only (Group 4):\n\n• Must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.\n\nHepatically-Impaired Participants Only (Groups 1, 2, and 3):\n\n* Must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (e.g., no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening, as determined by the investigator at screening and Day -1).\n* Must be classified by the investigator as CP Class A (Group 1), CP Class B (Group 2), or CP Class C (Group 3) at screening.\n* Participant must be stable on a concomitant medication and\u002For treatment regimen (defined as not starting a new treatment\u002Fmedication\\[s\\] or a change in the dosage or frequency of the concomitant medication\\[s\\] within at least 2 weeks prior to screening).\n\nAll Groups:\n\n* Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 45 kg\u002Fm2, inclusive.\n* All Females of Childbearing Potential (FOCBP) must have a negative pregnancy test at screening and Day -1.\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 participant's ability to participate in the study.\n* Have Type 1 diabetes mellitus or T2DM (Group 4)\n* Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.\n* History of long QT syndrome or prolonged QTcF.\n* Presence of unstable medical or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (e.g., currently unstable or uncompensated renal, cardiovascular, or respiratory disease).\n* Evidence of renal impairment at screening\n* Current liver transplant or anticipated to receive liver transplant within 2 months of screening or Day -1 (Group 1, 2 and 3).\n* Use of any of the prescription and non-prescription prohibited medications.\n* Concomitant immunosuppressive, steroid treatment.\n* Live or attenuated vaccines within 3 months prior to study intervention or live vaccinations planned during the trial.\n* History of severe allergy\u002Fhypersensitivity of AZD4144 or any of the excipients of the product.\n* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to study intervention in this study or, if known, 5 half-lives from last dose in the previous study to study intervention in this study, whichever is longest.",true,"ALL","18 Years","80 Years",{"count":157,"type":158},30,"ESTIMATED","INTERVENTIONAL",[161],"PHASE1","This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.",[164],"Hepatic Impairment",[164,166,167,168,169,94],"Mild hepatic impairment","Moderate hepatic impairment","Severe hepatic impairment","Matched Healthy normal","NOT_YET_RECRUITING","2026-08-20",{"date":173,"type":174},"2026-08-24","ACTUAL",{"date":173,"type":158},{"date":177,"type":158},"2027-05-28",{"name":5,"class":6},4]