[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100347507":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":56,"centralContacts":61,"locations":62,"responsibleParty":75,"collaborators":61,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":61,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":61,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":104,"whyStopped":61,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,17,20,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","In Part A, each subject will receive AZD9977 as a single dose on 4 different occasions under fasting conditions, separated by at least 48 hours.",[13,14,15,16],"Drug: Treatment A","Drug: Treatment B","Drug: Treatment C","Drug: Treatment D",{"label":18,"type":10,"description":11,"interventionNames":19},"Cohort 2",[13,14,15,16],{"label":21,"type":10,"description":11,"interventionNames":22},"Cohort 3",[13,14,15,16],{"label":24,"type":10,"description":11,"interventionNames":25},"Cohort 4",[13,14,15,16],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5","In Part B, each subject will receive one formulation from Part A chosen for further development, dose under fed conditions, followed by dose under fasted condition.",[13,14,15,16],[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Treatment A","Each subject will receive single dose of AZD9977 capsule under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and another dose under fasted condition.",[9,18,21,24,27],[37],"AZD9977 capsule, reference",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Treatment B","Each subject will receive single dose of AZD9977 HDL capsule under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and another dose under fasted condition.",[9,18,21,24,27],[43],"AZD9977 HDL capsule",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Treatment C","Each subject will receive single dose of AZD9977 ODL capsule under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and other dose under fasted condition.",[9,18,21,24,27],[49],"AZD9977 ODL capsule",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Treatment D","Each subject will receive single dose of AZD9977 tablet under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and another dose under fasted condition.",[9,18,21,24,27],[55],"AZD9977 tablet",[57],{"name":58,"affiliation":59,"role":60},"Pablo Forte Soto, MD, MSc, PhD","Dr.","PRINCIPAL_INVESTIGATOR",null,[63],{"facility":64,"status":61,"city":65,"state":61,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":61},"Research Site","Harrow","HA1 3UJ","United Kingdom","UK",{"type":70,"coordinates":71},"Point",[72,73],-0.33208,51.57835,{"lat":73,"lon":72},{"type":76,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100347507","phase-1-a-study-to-assess-the-reaction-of-body-for-four-different-formulations-of-azd9977-part-a-and-influence-of-food-and-lower-dose-of-a-selected-formulation-part-b-in-healthy-male-subjects-100347507",false,"NCT03804645","A Study to Assess the Reaction of Body for Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects","An Open-label, Randomized, Four-way Crossover Single Oral Dose Study Comparing the Pharmacokinetics of Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study specific procedures.\n2. Agree to use the methods of contraception.\n3. Healthy male subjects aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venipuncture at screening.\n4. 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 at screening.\n5. Subject judged at screening likely to complete and agree to eat a specified high fat standardized Food and Drug Administration (FDA) breakfast.\n\nExclusion Criteria:\n\n1. History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.\n2. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n3. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of IMP.\n4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the PI, including:\n\n   4.1. Serum potassium \\> 5.0 mmol\u002FL.\n5. Any clinically significant abnormal findings in vital signs, as judged by the PI, including:\n\n   5.1. Systolic BP \\\u003C 90 mmHg or \\> 140 mmHg. 5.2. Diastolic BP \\\u003C 50 mmHg or \\> 90 mmHg. 5.3. Pulse rate \\\u003C 45 or \\> 90 beats per minute.\n6. Any clinically significant abnormalities on 12-lead echocardiogram (ECG), as judged by the PI.\n7. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.\n8. Known or suspected history of drug abuse in the 12 months prior to screening, as judged by the PI.\n9. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of AZD9977 in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous Phase 1 study, are not excluded.\n10. Plasma donation within 1 month of screening or any blood donation\u002Floss more than 500 mL during the 3 months prior to screening.\n11. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977.\n12. Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening.\n13. Positive screen for drugs of abuse, alcohol or cotinine at screening or on admission to the study center.\n14. Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of AZD9977.\n15. Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol\u002Facetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of AZD9977 or longer if the medication has a long half life.\n16. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol in the 12 months prior to screening as judged by the PI.\n17. Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.\n18. Subjects who have previously received AZD9977.\n19. Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.\n20. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.",true,"MALE","18 Years","50 Years",{"count":89,"type":90},12,"ACTUAL","INTERVENTIONAL",[93],"PHASE1","AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. AZD9977 is a partial antagonist and partial agonist in reporter gene assays and has a different interaction pattern with the MR compared to eplerenone.\n\nThis study will assess the pharmacokinetics (PK) of four different Formulations of AZD9977 (Part A) and influence of food and lower dose of a selected formulation (Part B) in healthy male subjects.",[96],"Heart Failure",[98,99,100,101,102,103],"Mineralocorticoid receptor","Heart failure with preserved ejection fraction","Safety","Pharmacokinetics","Influence of Food","Bioavailability","COMPLETED","2021-04-14",{"date":107,"type":90},"2021-04-19",{"date":109,"type":90},"2019-02-05",{"date":111,"type":90},"2019-04-16",{"name":5,"class":6},1]