[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563137":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":44,"locations":49,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":44,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":44,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":92,"whyStopped":93,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Melinta Therapeutics, Inc.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Regimen A then B: Delafloxacin Tablet then Powder","EXPERIMENTAL","Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).",[13,14],"Drug: Delafloxacin","Drug: Delafloxacin Powder",{"label":16,"type":10,"description":17,"interventionNames":18},"Regimen B then A: Delafloxacin Powder then Tablet","Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Regimen C: Delafloxacin Powder","Participants will receive delafloxacin powder in fasted or fed states.",[14],{"label":24,"type":10,"description":21,"interventionNames":25},"Regimen D (Optional): Delafloxacin Powder",[14],[27,40],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Delafloxacin","Delafloxacin tablet",[9,16],[33,34,35,36,37,38,39],"Baxdela","Quofeni","Delabaxi","RX-3341","ABT-492","ABT-319492","WQ-3034",{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Delafloxacin Powder","Delafloxacin powder for oral suspension formulation",[9,16,20,24],null,[46],{"name":47,"affiliation":5,"role":48},"Medical Information","STUDY_DIRECTOR",[50],{"facility":51,"status":44,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":44},"Quotient Sciences","Ruddington","Nottingham","NG11 6JS","United Kingdom","UK",{"type":58,"coordinates":59},"Point",[60,61],-1.14953,52.89254,{"lat":61,"lon":60},{"type":64,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[66],{"name":67,"class":68},"Biomedical Advanced Research and Development Authority","FED","100563137","phase-1-a-study-comparing-the-bioavailability-of-a-taste-masked-delafloxacin-powder-for-oral-suspension-with-the-delafloxacin-tablet-in-healthy-adults-100563137",true,"NCT06612255","A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults","A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects","Key Inclusion Criteria:\n\n* Must agree to adhere to the protocol-specified contraception requirements.\n* Body mass index of 18.0 to 32.0 kilograms (kg)\u002Fmeter squared as measured at screening.\n* Weight ≥50 kg at screening.\n\nKey Exclusion Criteria:\n\n* Any history of hypersensitivity to delafloxacin or any other fluoroquinolones or previous history of tendon disorders related to fluoroquinolone administration.\n* History of clinically significant cardiovascular, renal, hepatic, respiratory, or particularly gastrointestinal disease.\n* Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and\u002For sinus infection or cold.\n* Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are not allowed.\n* Participants who do not agree to eat a high-fat breakfast.\n\nNote: Other inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","55 Years",{"count":80,"type":81},16,"ACTUAL","INTERVENTIONAL",[84],"PHASE1","This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.",[87],"Healthy",[29,33,89,90,91],"BARDA","Bioavailability","Taste-masked","TERMINATED","Study goals not met","2025-09-08",{"date":96,"type":81},"2025-09-26",{"date":98,"type":81},"2024-06-03",{"date":100,"type":81},"2024-09-11",{"name":5,"class":6},1]