[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450975":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":30,"locations":38,"responsibleParty":52,"collaborators":30,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":30,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":30,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":30,"overallStatus":74,"whyStopped":30,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Biogen","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"BIIB104 0.5 mg Reference Formulation (Fasted State)","ACTIVE_COMPARATOR","Participants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state.",[13],"Drug: BIIB104 Reference Formulation",{"label":15,"type":16,"description":17,"interventionNames":18},"BIIB104 0.5 mg Test Formulation (Fasted State)","EXPERIMENTAL","Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state.",[19],"Drug: BIIB104 Test Formulation",{"label":21,"type":16,"description":22,"interventionNames":23},"BIIB104 0.5 mg Test Formulation (Fed State)","Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","BIIB104 Reference Formulation","Administered as specified in the treatment arm",[9],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"BIIB104 Test Formulation",[15,21],[35],{"name":36,"affiliation":5,"role":37},"Medical Director","STUDY_DIRECTOR",[39],{"facility":40,"status":30,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":30},"QPS MRA","Miami","Florida","33143","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.19366,25.77427,{"lat":50,"lon":49},{"type":53,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100450975","phase-1-a-study-to-evaluate-the-relative-bioavailability-of-two-formulations-of-biib104-and-assess-the-effect-of-food-on-the-pharmacokinetics-of-biib104-following-administration-of-a-single-fixed-oral-dose-of-biib104-in-healthy-participants-100450975",false,"NCT05152485","A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants","A Phase 1, Randomized, Open-Label, Parallel-Arm Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants","Key Inclusion Criteria:\n\n* Has a body mass index (BMI) between 18 and 30 kilogram per square meter (kg\u002Fm\\^2), inclusive and a total body weight \\>50 kilograms \\[110 pound (lb)\\].\n\nKey Exclusion Criteria:\n\n* Participates in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and\u002For during study participation.\n* Previously participated in this study or previous studies with BIIB104.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"MALE","18 Years","55 Years",{"count":66,"type":67},36,"ACTUAL","INTERVENTIONAL",[70],"PHASE1","The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.\n\nThe secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.",[73],"Healthy Volunteers","COMPLETED","2023-04-13",{"date":77,"type":67},"2023-04-18",{"date":79,"type":67},"2021-12-15",{"date":81,"type":67},"2022-01-31",{"name":5,"class":6},1]