Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

• Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  Plasma maximum serum concentration of ceftaroline Area-under-the-concentration-time curve of ceftaroline: Time frame Predose (time zero [0]) to 12 hours Total body clearance of ceftaroline Apparent volume of distribution of ceftaroline Elimination rate constant of ceftaroline Elimination half-life of ceftaroline Renal clearance of ceftaroline: Time frame Predose (time zero [0]) to 12 hours Amount of ceftaroline excreted in the urine: Time frame Predose (time zero [0]) to 12 hours
  
  

• To evaluate the safety and tolerability of intravenous ceftaroline [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  Number of participants with adverse events Number of participants with changes in clinical laboratories Number of participants with changes in vital sign assessments
  
  

This study is planned to be a Phase I, open-label, single period, single-dose pharmacokinetic study conducted in 32 healthy adult male and female subjects. Adult subjects will be recruited and assigned to one of four groups based on their body mass index and total body weight. Subject will receive a single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion. Serial blood and urine samples will be collected over the next 12 hours to determine serum and urinary pharmacokinetics of ceftaroline. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests (serum chemistry and hematology), pregnancy testing (female subjects only), monitoring of adverse events, and recording of concomitant medications.