Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Phase 1

Completed

• Conditions: Drug Safety
• Interventions: Drug: Ceftaroline

• Registration Number: NCT01648127
• Lead Sponsor: Keith A. Rodvold

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ceftaroline	Ceftaroline	Ceftaroline intravenous 600 mg single dose

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects	12 hours	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

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of intravenous ceftaroline	24 hours	Number of participants with adverse events Number of participants with changes in clinical laboratories Number of participants with changes in vital sign assessments

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States