NCT01648127

Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Keith A. Rodvold · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Drug Safety

Interventions

Type	Name	Description
DRUG	Ceftaroline	A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-07-24
• Last updated: 2013-03-14

Locations

1 site across 1 country: United States