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Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adults (18-55 Years)
Sponsor: Basilea Pharmaceutica
Summary
This was a Phase 1, open-label, single-center Pharmacokinetic (PK) study to evaluate plasma and intrapulmonary pharmacokinetics (PK) of ceftibuten and ledaborbactam in healthy adult participants. Approximately 31 participants were planned to be enrolled in two groups, with approximately 25 in Group 1 and approximately six in Group 2.
Official title: A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2024-11-04
Completion Date
2025-03-17
Last Updated
2026-08-24
Healthy Volunteers
Yes
Conditions
Interventions
ledaborbactam etzadroxil
Five doses of ledaborbactam etzadroxil administered orally every 12 hours
ceftibuten
Five doses of ceftibuten administered orally every 12 hours
Locations (1)
Pulmonary Associates
Phoenix, Arizona, United States