A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients

• The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients [ Time Frame: up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up). ] [ Designated as safety issue: No ]
  

• To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients. [ Time Frame: Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up) ] [ Designated as safety issue: No ]
  
• To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population. [ Time Frame: Throughout the study from Day -1 through the post-study follow up ] [ Designated as safety issue: No ]
  

This is an open-label (all people involved know the identity of the intervention), parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). There are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg