Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Completed · Phase 1

Conditions studied: Drug Safety

In brief

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.

Key facts

Study ID

NCT01648127

Run by

Keith A. Rodvold

People needed

32

Starts

2012-07-01

Expected to finish

2013-02-01

Last updated by the study team

2013-03-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy adult subjects
• nonsmokers within the last 1 year
• body mass index and total body weight within specific categories

You may not qualify if…

• 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

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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