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.

A Phase 1, Open-label Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects

Study Overview

• Status: Completed
• Conditions: Healthy Subjects (HS)
• Intervention / Treatment: Drug: zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit Inc. 3402 Kinsman Boulevard Madison, Wisconsin 53704 USA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body mass index between 18.5 and 29.9 kg/m2, inclusive at Screening and Check-in (Day -1).
• In good health, determined by no clinically significant findings from medical history, physical examination (at Check-in [Day -1]), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
• Blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic, unless deemed not clinically significant by the Investigator (or designee).
• History of a minimum of 1 bowel movement per day.

Exclusion Criteria:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
• History of alcoholism or drug/chemical abuse within 1 year prior to Check-in (Day -1).
• Alcohol consumption of >28 units per week for males. One unit of alcohol equals 12 oz. (360 mL) of beer, 1½ oz. (45 mL) of liquor, or 5 oz. (150 mL) of wine.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 14 days prior to Check-in.
• Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount Excreted in Urine (Aeu)	The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the amount excreted in urine (Aeu).	7 days
Cumulative Aeu in urine (Cum Aeu)	The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative Aeu (Cum Aeu).	7 days
Percentage excreted in urine (feu):	The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the percentage excreted in urine (feu).	7 days
Cumulative feu in urine(Cum feu):	The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative feu (Cum feu).	7 days
Renal clearance (zidebactam only; CLR):	The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the renal clearance (zidebactam only; CLR).	7 days
Amount excreted in feces (Aef):	The primary PK outcome endpoints of total radioactivity derived from fecal collections were the amount excreted in feces (Aef).	7 days
Cumulative Aef in feces (Cum Aef):	The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative Aef (Cum Aef).	7 days
Percentage excreted in feces (fef):	The primary PK outcome endpoints of total radioactivity derived from fecal collections were the percentage excreted in feces (fef).	7 days
Cumulative fef in feces (Cum fef):	The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative fef (Cum fef).	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Profile of [14C]-zidebactam	The secondary metabolite endpoints is the metabolic profile of [14C]-zidebactam	7 days
Identification of [14C]-zidebactam metabolites	The identification of [14C]-zidebactam metabolites is a secondary metabolite endpoint.	7 days
Incidence and severity of AEs	The incidence and severity of adverse events (AEs) is a secondary safety outcome measure.	7 Days
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results	The incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results, is a secondary safety outcome measure.	7 days
12-lead electrocardiogram (ECG) parameters	The assessment of 12-lead electrocardiogram ECG QT Interval parameters is included as a secondary safety outcome measure.	7 days
Vital Signs -Supine Blood Pressure	Supine Blood Pressure is a secondary outcome measure	7 days
Physical Examinations	Physical examinations is a secondary safety outcome measure. To assess the outcome measure a questionnaire includes below mentioned measurements. General Appearance Skin Lymph Nodes HEENT Neck Thorax/Lungs Cardiovascular Abdomen Musculoskeletal Neurological	7 days
Vital Signs- supine pulse rate	supine pulse rate is a secondary outcome measure	7 days
Vital Signs- respiratory rate	respiratory rate is a secondary outcome measure	7 Days
Vital signs- oral body temperature	oral body temperature is a secondary outcome measure	7 days

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: Covance

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): January 20, 2018
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: zidebactam
• Other Study ID Numbers: W-5107-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No