[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572469":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":57,"centralContacts":62,"locations":68,"responsibleParty":91,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":41,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":41,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":71,"whyStopped":41,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Basilea Pharmaceutica","INDUSTRY",[8,17,21,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1","EXPERIMENTAL","Part 1 will enroll at least 16 participants who will receive a single oral dose of ceftibuten and ledaborbactam etzadroxil following a 10-hour fast on 3 occasions in a fixed sequence: (a) Ceftibuten and ledaborbactam etzadroxil as separate capsules; (b) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination (FDC) capsules; (c) Ceftibuten-ledaborbactam etzadroxil as FDC capsules after 5 days of esomeprazole orally once daily",[13,14,15,16],"Drug: Ledaborbactam etzadroxil","Drug: Ceftibuten","Drug: Ceftibuten-ledaborbactam etzadroxil","Drug: Esomeprazole",{"label":18,"type":10,"description":19,"interventionNames":20},"Part 2 Group 1","Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group)",[15],{"label":22,"type":10,"description":23,"interventionNames":24},"Part 2 Group 2","Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group)",[15],{"label":26,"type":10,"description":27,"interventionNames":28},"Part 3 (Groups 1, 2, 4, 5, 6)","Part 3 will enroll up to 50 participants. Each will receive oral doses of ceftibuten and\u002For ledaborbactam etzadroxil capsules (combined as FDC when administered together) in fed conditions",[13,14],{"label":30,"type":31,"description":32,"interventionNames":33},"Part 3 Group 3","ACTIVE_COMPARATOR","Part 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate",[34],"Drug: amoxicillin-clavulanate",[36,42,45,49,53],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Ledaborbactam etzadroxil","capsules",[9,26],null,{"type":37,"name":43,"description":39,"armGroupLabels":44,"otherNames":41},"Ceftibuten",[9,26],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":41},"Ceftibuten-ledaborbactam etzadroxil","Fixed Dose Combination (FDC)",[9,18,22],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":41},"Esomeprazole","40 mg capsule",[9],{"type":37,"name":54,"description":55,"armGroupLabels":56,"otherNames":41},"amoxicillin-clavulanate","500 mg-125 mg oral doses",[30],[58],{"name":59,"affiliation":60,"role":61},"Kamal Hamed, MD","Basilea Pharmaceutica International Ltd, Allschwil","STUDY_DIRECTOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":41,"email":67},"Karine Litherland, PhD","CONTACT","+41616061111","Karine.Litherland@basilea.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"ICON, Clinical Research Phase I Unit","RECRUITING","Lenexa","Kansas","66219","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-94.73357,38.95362,{"lat":81,"lon":80},[84,88],{"name":85,"role":65,"phone":86,"phoneExt":41,"email":87},"Daniel Dickerson, MD. PhD, FAAFP","913-205-4397","Daniel.Dickerson@iconplc.com",{"name":89,"role":90,"phone":41,"phoneExt":41,"email":41},"Daniel Dickerson, MD, PhD, FAAFP","PRINCIPAL_INVESTIGATOR",{"type":92,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[94],{"name":95,"class":96},"Biomedical Advanced Research and Development Authority","FED","100572469","phase-1-safety-and-pk-of-ceftibuten-ledaborbactam-etzadroxil-fixed-dose-combination-100572469",false,"NCT06733675","Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination","A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil","Inclusion Criteria:\n\n* Healthy adult male or female, between 18 and 55 years of age\n* Body mass index ≥ 18 and ≤ 32 kg\u002Fm2\n* Laboratory values meeting defined laboratory ranges\n* Males or non-pregnant, non-lactating females\n\nExclusion Criteria:\n\n* History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug\n* Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant\n* Positive alcohol, drug or tobacco use\u002Ftest",true,"ALL","18 Years","55 Years",{"count":109,"type":110},96,"ESTIMATED","INTERVENTIONAL",[113],"PHASE1","This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.",[116,117,118,119,120],"Healthy Volunteer","Pharmacokinetics","Safety","Drug-Drug Interaction (DDI)","FDC",[122,43,38],"Healthy Volunteers","2026-07-07",{"date":125,"type":126},"2026-07-09","ACTUAL",{"date":128,"type":126},"2025-01-07",{"date":130,"type":110},"2026-12-30",{"name":5,"class":6},1]