A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
NCT06547554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-11-28
Summary
A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants
Conditions
Interventions
- DRUG
-
Xeruborbactam
Experimental
- DRUG
-
Cefiderocol
Experimental
- DRUG
-
Xeruborbactam/Cefiderocol
A combination of Xeruborbactam and Cefiderocol.
- DRUG
-
Dextrose 5% in water
Placebo
Sponsors & Collaborators
-
Shionogi Inc.
collaborator INDUSTRY -
Biomedical Advanced Research and Development Authority
collaborator FED -
Qpex Biopharma, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-04
- Primary Completion
- 2025-10-27
- Completion
- 2025-10-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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