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

NCT ID: NCT07247942

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2019-01-30

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

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Body mass index between 18.5 and 29.9 kg/m2, inclusive at Screening and Check-in (Day -1).

2. 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).

3. 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).

4. History of a minimum of 1 bowel movement per day.

Exclusion Criteria

• 1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.

2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.

3. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in (Day -1).

4. 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.

5. 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.

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W-5107-103

Identifier Type: -

Identifier Source: org_study_id