[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100322787":3},{"organization":4,"armGroups":7,"interventions":47,"overallOfficials":64,"centralContacts":59,"locations":69,"responsibleParty":83,"collaborators":59,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":59,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":59,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":106,"whyStopped":59,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Takeda","INDUSTRY",[8,15,19,23,27,31,35,39,43],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Cohort 1: TAK-788","EXPERIMENTAL","TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.",[13,14],"Drug: TAK-788","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 1 Cohort 2: TAK-788","TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part 1 Cohort 3: TAK-788","TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 1 Cohort 4: TAK-788","TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Part 1 Cohort 5: TAK-788","TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Part 2: TAK-788 Fed + TAK-788 Fasted","TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.",[13],{"label":36,"type":10,"description":37,"interventionNames":38},"Part 2: TAK-788 Fasted + TAK-788 Fed","TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.",[13],{"label":40,"type":10,"description":41,"interventionNames":42},"Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)","TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.",[13],{"label":44,"type":10,"description":45,"interventionNames":46},"Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)","TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.",[13],[48,55,60],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","TAK-788","TAK-788 capsules.",[9,16,20,24,28,36,32],[54],"AP32788",{"type":49,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Placebo","TAK-788 placebo-matching capsules.",[9,16,20,24,28],null,{"type":49,"name":50,"description":61,"armGroupLabels":62,"otherNames":63},"TAK-788 DiC.",[40,44],[54],[65],{"name":66,"affiliation":67,"role":68},"Medical Director","Millennium Pharmaceuticals, Inc.","STUDY_DIRECTOR",[70],{"facility":71,"status":59,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":59},"PRA Health Sciences","Salt Lake City","Utah","84124","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-111.89105,40.76078,{"lat":81,"lon":80},{"type":84,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100322787","phase-1-a-study-to-evaluate-the-pharmacokinetics-pk-safety-and-tolerability-of-tak-788-followed-by-evaluation-of-the-effects-of-a-low-fat-meal-on-tak-788-pk-and-evaluation-of-relative-bioavailability-of-tak-788-capsules-in-healthy-participants-100322787",true,"NCT03482453","A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants","Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects","Inclusion Criteria:\n\n1. Body weight of greater than or equal to (\\>=) 45 kilogram (kg) (women) or \\>=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg\u002Fm\\^2) at screening.\n2. Nonsmoker (never smoked or greater than \\[\\>\\] 20 years from last occurrence of smoking).\n3. Normal organ function including hepatic, renal, and bone marrow function.\n\nExclusion Criteria:\n\n1. Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.\n2. Pulmonary infection ongoing or within 30 days of informed consent.\n3. Inability to undergo venipuncture and\u002For tolerate venous access.\n4. Inability to tolerate multiple blood sampling.\n5. Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.","ALL","18 Years","55 Years",{"count":96,"type":97},69,"ACTUAL","INTERVENTIONAL",[100],"PHASE1","The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.",[103],"Healthy Volunteers",[105],"Drug Therapy","COMPLETED","2020-01-16",{"date":109,"type":97},"2020-01-29",{"date":111,"type":97},"2018-03-28",{"date":113,"type":97},"2019-01-18",{"name":67,"class":6},1]