Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Inf… (NCT07247942) | Clinical Trial Compass
CompletedPhase 1
Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.
United States8 participantsStarted 2017-12-13
Plain-language 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
Who can participate
Age range18 Years – 55 Years
SexMALE
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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 …