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

NCT07247942 | Completed Phase 1 FDA Drug

• 1 other identifier: W-5107-103
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

zidebactam

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (10)

• Metabolic Profile of [14C]-zidebactam

  7 days

• Identification of [14C]-zidebactam metabolites

  7 days

• Incidence and severity of AEs

  7 Days

• Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results

  7 days

• 12-lead electrocardiogram (ECG) parameters

  7 days

Study Arms (1)

zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour

EXPERIMENTAL

Drug: zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour

Interventions

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 following at least an 8-hour fast from food (not including water).

zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wockhardt: lead
• Covance: collaborator

Study Sites (1)

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

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 25, 2025
• Study Start: December 13, 2017
• Primary Completion: January 20, 2018
• Study Completion: January 30, 2019
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)