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COMPLETED
NCT06665555
PHASE1

Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adults (18-55 Years)

Sponsor: Basilea Pharmaceutica

View on ClinicalTrials.gov

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

Interventions

DRUG

ledaborbactam etzadroxil

Five doses of ledaborbactam etzadroxil administered orally every 12 hours

DRUG

ceftibuten

Five doses of ceftibuten administered orally every 12 hours

Locations (1)

Pulmonary Associates

Phoenix, Arizona, United States