Trials / Recruiting
RecruitingNCT06733675
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Basilea Pharmaceutica · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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 intervention.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ledaborbactam etzadroxil | capsules |
| DRUG | Ceftibuten | capsules |
| DRUG | Ceftibuten-ledaborbactam etzadroxil | Fixed Dose Combination (FDC) |
| DRUG | Esomeprazole | 40 mg capsule |
Timeline
- Start date
- 2025-01-07
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2024-12-13
- Last updated
- 2025-12-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06733675. Inclusion in this directory is not an endorsement.