[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591358":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":41,"locations":46,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":41,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":41,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":90,"whyStopped":41,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment ABC","EXPERIMENTAL","Participants will receive Treatment A (reference, fasted), balcinrenone\u002Fdapagliflozin capsule on Day 1 and then followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone\u002Fdapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment C (quinidine, fasted), balcinrenone\u002Fdapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone\u002Fdapagliflozin administration, respectively).",[13,14],"Drug: balcinrenone\u002F dapagliflozin","Drug: quinidine",{"label":16,"type":10,"description":17,"interventionNames":18},"Treatment ACB","The participants will receive Treatment A (reference, fasted), balcinrenone\u002Fdapagliflozin capsule on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone\u002Fdapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone\u002Fdapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone\u002Fdapagliflozin capsule dosed together with food.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Treatment BCA","The participants will receive Treatment B (fed), balcinrenone\u002Fdapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone\u002Fdapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone\u002Fdapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone\u002Fdapagliflozin capsule.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Treatment BAC","The participants will receive Treatment B (fed), balcinrenone\u002Fdapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone\u002Fdapagliflozin capsule and then followed by washout period of 72 hours. On Day 7 participants will receive Treatment C (quinidine, fasted), balcinrenone\u002Fdapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone\u002Fdapagliflozin administration, respectively).",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Treatment CAB","The participants will receive Treatment C (quinidine, fasted), balcinrenone\u002Fdapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone\u002Fdapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone\u002Fdapagliflozin capsule and then followed by washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone\u002Fdapagliflozin capsule dosed together with food.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Treatment CBA","The participants will receive Treatment C (quinidine, fasted), balcinrenone\u002Fdapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone\u002Fdapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone\u002Fdapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone\u002Fdapagliflozin capsule.",[13,14],[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","balcinrenone\u002F dapagliflozin","Participants will be receiving balcinrenone\u002F dapagliflozine in fasted or fed condition.",[9,16,24,20,28,32],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"quinidine","Participants will be receiving quinidine orally in fasted condition.",[9,16,24,20,28,32],[47],{"facility":48,"status":41,"city":49,"state":41,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":41},"Research Site","Harrow","HA1 3UJ","United Kingdom","UK",{"type":54,"coordinates":55},"Point",[56,57],-0.33208,51.57835,{"lat":57,"lon":56},{"type":60,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[62],{"name":63,"class":6},"Parexel","100591358","phase-1-a-study-to-investigate-the-effect-of-food-on-balcinrenonedapagliflozin-pharmacokinetics-in-fed-and-fasted-state-and-pharmacokinetics-of-balcinrenone-when-dosed-with-a-p-gp-inhibitor-in-healthy-participants-100591358",false,"NCT06979388","A Study to Investigate the Effect of Food on Balcinrenone\u002FDapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.","A Phase I, Randomised, Single-dose, Open-label, 3-period, 3-treatment, 3-way Crossover Study to Assess the Effect of Food on Balcinrenone\u002FDapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.","Main Inclusion Criteria:\n\n* Have a Body Mass Index (BMI) between 18 and 30 kg\u002Fm2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.\n* All females of childbearing potential must have a negative pregnancy test.\n* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.\n\nMain Exclusion Criteria:\n\n* History of any clinically important disease or disorder which 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* 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 important illness, medical\u002Fmajor surgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* Any clinically important abnormalities in clinical chemistry, haematology, urinalysis or vital signs.\n* Positive result for serum hepatitis B surface antigen, hepatitis C antibody, and HIV antibody\n* History of long QT syndrome or history of additional risk factors for QT prolongation - for example a family history of long QT syndrome or the use of concomitant medications known to prolong the QT\u002FQTc interval. Any clinically significant abnormalities on 12-lead ECG at the Screening Visit, as judged by the investigator, including but not limited to any significant arrythmia, conduction abnormalities, and\u002For prolonged QTcF \\> 450 ms.\n* Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to Screening Visit.\n* History of alcohol or drug abuse. Positive screen for drugs of abuse, alcohol or cotinine.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity.\n* History of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone, dapagliflozin and quinidine. Any contraindications listed for dapagliflozin and quinidine.\n* Use of drugs with enzyme inducing properties within 3 weeks prior to the first administration of study intervention.\n* Use of any prescribed or nonprescribed medication, herbal remedies or intake of \\> 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention\n* Plasma donation within one month of screening or any blood donation\u002Fblood loss \\> 500 mL during the 3 months prior to screening.",true,"ALL","18 Years","55 Years",{"count":76,"type":77},14,"ACTUAL","INTERVENTIONAL",[80],"PHASE1","The main purpose of this study is to assess the effect of food on balcinrenone\u002F dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participants.",[83],"Healthy Participants",[85,86,87,88,89],"Food effect","Mineralocorticoid receptor modulator","P-glycoprotein inhibitor","Fed and fasted state","Standardised high-fat and high-calorie meal","COMPLETED","2025-08-11",{"date":93,"type":77},"2025-08-12",{"date":95,"type":77},"2025-05-20",{"date":97,"type":77},"2025-07-12",{"name":5,"class":6},1]