Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Recruiting now · Phase 1
Conditions studied: Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC
In brief
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.
Key facts
- Study ID
- NCT06733675
- Run by
- Basilea Pharmaceutica
- People needed
- 96
- Starts
- 2025-01-07
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adult male or female, between 18 and 55 years of age
- Body mass index ≥ 18 and ≤ 32 kg/m2
- Laboratory values meeting defined laboratory ranges
- Males or non-pregnant, non-lactating females
You may not qualify if…
- History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
- Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
- Positive alcohol, drug or tobacco use/test
Where it is running
- ICON, Clinical Research Phase I Unit — Lenexa, Kansas, United States (enrolling)
Full record on ClinicalTrials.gov
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