[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100237689":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":28,"locations":37,"responsibleParty":49,"collaborators":28,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":28,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":28,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":74,"whyStopped":28,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Fasting","EXPERIMENTAL","Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered at the end of a 10-hour fast.",[13],"Drug: AZD0585",{"label":15,"type":10,"description":16,"interventionNames":17},"Before meal","Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"After meal","Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","AZD0585","Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.",[19,15,9],null,[30,34],{"name":31,"affiliation":32,"role":33},"Kei Sakamoto, MD, PhD","Sugioka Memorial Hospital, Medical Co. LTA","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":36},"Torbjörn Lundström, MD","STUDY_DIRECTOR",[38],{"facility":39,"status":28,"city":40,"state":28,"zip":28,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":28},"Research Site","Fukuoka","Japan","JP",{"type":44,"coordinates":45},"Point",[46,47],130.41667,33.6,{"lat":47,"lon":46},{"type":50,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100237689","phase-1-a-study-to-investigate-the-effect-of-food-on-pharmacokinetics-of-total-epa-and-total-dha-of-azd0585-in-healthy-male-japanese-subjects-100237689",true,"NCT02372344","A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects","A Phase I, Single Centre, Randomized, Open-Label, Three-Period Crossover Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA With a Single 4 g Dose of AZD0585 in Healthy Male Japanese Subjects","Inclusion Criteria:\n\n* Healthy Japanese male, 20 to 45 years of age (inclusive).\n* Body mass index (BMI) ≥ 18.5 and ≤ 25 (kg\u002Fm2).\n* Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical findings). Hemoglobin level must be ≥ the lower limit of study centre reference range. 12-Lead ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF) should be \\> 340 msec and \\\u003C 450 msec.\n* No habitual use of drug(s) and tobacco\u002Fnicotine-containing products for a minimum of 3 months prior to first dosing.\n* Subjects must be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form prior to admission to this study and follow the restrictions and procedures outlined for the study.\n\nExclusion Criteria:\n\n* Past history of psychological or physical disorder which may affect the objectives of this study, in the opinion of the PI.\n* An individual who has abnormal laboratory values (ie, suggesting hepatic, renal, cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate current or past medical history for participation based on the decision of the PI.\n* A history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.\n* Had used fish oil, other EPA- and\u002For DHA-containing supplements within 2 months prior to first admission day.\n* Have serum (or plasma) EPA and\u002For DHA concentrations exceeding the upper limit of reference range for the \"fatty acids profile, four-fraction\" test, determined at Visit 1.","MALE","20 Years","45 Years",{"count":62,"type":63},72,"ACTUAL","INTERVENTIONAL",[66],"PHASE1","The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.",[69],"Healthy",[71,72,25,73],"the effect of food timing on PK","the effect of food timing on Safety and Tolerability","Japanese","COMPLETED","2016-04-11",{"date":77,"type":78},"2016-05-16","ESTIMATED",{"date":80,"type":28},"2015-03",{"date":82,"type":63},"2015-05",{"name":5,"class":6},1]