Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in healthy subjects who are normal weight, overweight, and obese.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Keith A. Rodvold
• Collaborator: Forest Laboratories
• Treatments: Ceftaroline fosamil; Cephalosporins

Criteria

Inclusion Criteria:

• healthy adult subjects

• nonsmokers within the last 1 year

• body mass index and total body weight within specific categories

Exclusion Criteria:

• history of significant hypersensitivity reaction or intolerance to ceftaroline or beta-lactam agents or heparin

• aspartate or alanine aminotransferase >3 times the upper limit of normal

• estimated creatinine clearance <60 mL/minute and serum creatinine >1.5 mg/dL

• female subjects who are pregnant or breast feeding

• history of alcohol or substance abuse or dependence within the last 1 year

• use of prescription or nonprescription drugs within last 7 to 14 days

• participations in a clinical trials within last 30 days

• donated blood (>500 mL) within the last 56 days