[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100348086":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":71,"centralContacts":49,"locations":75,"responsibleParty":87,"collaborators":49,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":49,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":49,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":111,"whyStopped":49,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"LEO Pharma","INDUSTRY",[8,16,22,28,31,34,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1-1","ACTIVE_COMPARATOR","Part 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation\u002Ftreatment period): LEO 32731 modified release tablet; LEO 32731 blend, hard capsule; LEO 32731 API hard capsule (reference formulation).",[13,14,15],"Drug: LEO 32731 modified release tablet","Drug: LEO 32731 blend, hard capsule","Drug: LEO 32731 API, hard capsule",{"label":17,"type":10,"description":18,"interventionNames":19},"Group 1-2","Part 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation\u002Ftreatment period): LEO 32731 soft capsule; LEO 32731 gastro-resistant capsule; LEO 32731 API hard capsule (reference formulation).",[15,20,21],"Drug: LEO 32731 soft capsule","Drug: LEO 32731 gastro-resistant capsule",{"label":23,"type":24,"description":25,"interventionNames":26},"Group 2-1","EXPERIMENTAL","Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition\u002Ftreatment period): fasted, after low-fat breakfast, after high-fat breakfast.\n\nThe formulation depends on the outcome of Part 1.",[27],"Drug: LEO 32731",{"label":29,"type":24,"description":25,"interventionNames":30},"Group 2-2",[27],{"label":32,"type":24,"description":25,"interventionNames":33},"Group 2-3",[27],{"label":35,"type":36,"description":37,"interventionNames":38},"Group 3-1","PLACEBO_COMPARATOR","Subjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.",[27,39],"Other: Placebo",{"label":41,"type":36,"description":37,"interventionNames":42},"Group 3-2",[27,39],[44,50,54,57,60,63,67],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","LEO 32731 modified release tablet","At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.",[9],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"LEO 32731 blend, hard capsule","At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.",[9],{"type":45,"name":55,"description":52,"armGroupLabels":56,"otherNames":49},"LEO 32731 API, hard capsule",[9,17],{"type":45,"name":58,"description":52,"armGroupLabels":59,"otherNames":49},"LEO 32731 soft capsule",[17],{"type":45,"name":61,"description":52,"armGroupLabels":62,"otherNames":49},"LEO 32731 gastro-resistant capsule",[17],{"type":45,"name":64,"description":65,"armGroupLabels":66,"otherNames":49},"LEO 32731","At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.",[23,29,32,35,41],{"type":68,"name":69,"description":65,"armGroupLabels":70,"otherNames":49},"OTHER","Placebo",[35,41],[72],{"name":73,"affiliation":5,"role":74},"Medical Expert","STUDY_DIRECTOR",[76],{"facility":77,"status":49,"city":78,"state":49,"zip":49,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":49},"LEO Pharma Investigational Site","Leeds","United Kingdom","UK",{"type":82,"coordinates":83},"Point",[84,85],-1.54785,53.79648,{"lat":85,"lon":84},{"type":88,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100348086","phase-1-a-trial-to-investigate-the-safety-tolerability-and-drug-levels-in-blood-after-single-and-multiple-doses-of-leo-32731-in-healthy-people-100348086",false,"NCT03812198","A Trial to Investigate the Safety, Tolerability, and Drug Levels in Blood After Single and Multiple Doses of LEO 32731 in Healthy People","A Phase 1, 3-part, Single (Open-label) and Multiple (Double-blind, Placebo-controlled) Oral Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of LEO 32731 Formulations in Healthy Subjects","Key inclusion criteria:\n\n* Age 18 to 65 years, inclusive.\n* Body mass index of 18.5 to 29.9 kg\u002Fm2, inclusive.\n* In good health, at the discretion of the investigator, as determined by: medical history, physical examination, vital sign assessment (specifically, blood pressure must be within normal reference range), 12-lead ECG, clinical laboratory evaluations, aspartate aminotransferase and alanine aminotransferase not above the upper limit of normal (Gilbert's syndrome is not acceptable).\n* Female subjects of childbearing potential must be willing to use a highly effective form of birth control in conjunction with a barrier method of contraception throughout the trial and for at least 90 days after final follow-up.\n* Male subjects with a female partner of childbearing potential must be willing to use a highly effective form of birth control in conjunction with male barrier method of contraception (i.e. male condom with spermicide) throughout the trial and for at least 90 days after final follow-up.\n\nKey exclusion criteria:\n\n* Systemic or topical treatment within 14 days prior to first dose administration unless in the opinion of the investigator the medication will not interfere with the trial procedures or compromise safety.\n* Any medications, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to first dose administration.\n* Subjects who smoke more than an average of 10 cigarettes per day.\n* History of chronic alcohol or drug abuse within 12 months prior to screening.\n* Subjects with ≥3 bowel movements per day.\n* Any disorder which is not stable and could: Affect the safety of the subject throughout the trial; Influence the findings of the trial; Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, GI, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders and major physical impairment.",true,"ALL","18 Years","65 Years",{"count":101,"type":102},66,"ACTUAL","INTERVENTIONAL",[105],"PHASE1","This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4 different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in 3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will participate in 3 treatment periods.",[108],"Healthy",[110],"healthy","COMPLETED","2019-06-28",{"date":114,"type":102},"2019-07-01",{"date":116,"type":102},"2019-01-22",{"date":118,"type":102},"2019-06-13",{"name":5,"class":6},1]