Healthy Subjects (HS)Phase 1NCT07247942
Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.
A Phase 1 study testing zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour in people with Healthy Subjects (HS), run by Wockhardt at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 30 Jan 2019
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc. 3402 Kinsman Boulevard Madison, Wisconsin 53704 USA
Madison, Wisconsin, 53704
About this study
Official title: 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
Read the 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)
- Being tested
- zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour
- Keywords
- zidebactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hourDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour | Experimental | Not described Receives: Drug: zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 7 days
Secondary outcomes (10)
Metabolic Profile of [14C]-zidebactam
The secondary metabolite endpoints is the metabolic profile of [14C]-zidebactam
Measured: 7 days
Identification of [14C]-zidebactam metabolites
The identification of [14C]-zidebactam metabolites is a secondary metabolite endpoint.
Measured: 7 days
Incidence and severity of AEs
The incidence and severity of adverse events (AEs) is a secondary safety outcome measure.
Measured: 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.
Measured: 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.
Measured: 7 days
Vital Signs -Supine Blood Pressure
Supine Blood Pressure is a secondary outcome measure
Measured: 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
Measured: 7 days
Vital Signs- supine pulse rate
supine pulse rate is a secondary outcome measure
Measured: 7 days
Vital Signs- respiratory rate
respiratory rate is a secondary outcome measure
Measured: 7 Days
Vital signs- oral body temperature
oral body temperature is a secondary outcome measure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start13 Dec 2017
- Primary completion20 Jan 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247942
- Sponsor's protocol ID
- W-5107-103
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No