Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.
NCT07247942 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-02-18
Summary
A Phase 1, Open-label Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects
Conditions
- Healthy Subjects (HS)
Interventions
- DRUG
-
zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour
zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour following at least an 8-hour fast from food (not including water).
Sponsors & Collaborators
-
Covance
collaborator INDUSTRY -
Wockhardt
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-13
- Primary Completion
- 2018-01-20
- Completion
- 2019-01-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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