NCT07247942

Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.

A Phase I, Open-label Study of the Metabolism and Excretion of [14C]-Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Wockhardt · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

The primary objectives of the study are: * To determine mass balance and routes of elimination of \[zidebactam following administration of a single 1g (approximately 200 μCi) radiolabeled intravenous (IV) infusion of zidebactam in healthy male subjects * To assess the pharmacokinetics (PK) of a single IV infusion of zidebactam * To determine the whole blood and plasma concentrations of total radioactivity following a single IV infusion of -zidebactam * To determine the urinary and fecal recovery of the total administered radioactive dose The secondary objectives of the study are: * To characterize and identify metabolites of zidebactam in plasma, urine, and feces, as applicable * To determine plasma and urine concentrations of non-radiolabeled zidebactam * To assess the safety and tolerability of zidebactam

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-12-13
• Primary completion: 2018-01-20
• Completion: 2019-01-30
• First posted: 2025-11-25
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study