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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects (HS)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07247942

W-5107-103

Details and patient eligibility

About

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

Full 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

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

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

Experimental group

Treatment:

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