Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2
| Condition(s) | Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). 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 and 43 days for Part 2. All participants will be screened within 28 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 in |
| Who can participate | Inclusion Criteria: * 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 Exclusion Criteria: * 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 |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Basilea Pharmaceutica |
| Locations | Lenexa, Kansas, United States |
| Start date | 2025-01-07 |
| NCT ID | NCT06733675 |
| Official listing | https://clinicaltrials.gov/study/NCT06733675 |