Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Drug Safety
• Intervention / Treatment: Drug: Ceftaroline

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ceftaroline; Ceftaroline intravenous 600 mg single dose	Drug: Ceftaroline; A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion; Other Names: Teflaro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects	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	12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Keith A. Rodvold
• Collaborators: Forest Laboratories
• Investigators: Principal Investigator: Keith A Rodvold, Pharm.D., University of Illinois at Chicago

Publications and helpful links

General Publications

• Justo JA, Mayer SM, Pai MP, Soriano MM, Danziger LH, Novak RM, Rodvold KA. Pharmacokinetics of ceftaroline in normal body weight and obese (classes I, II, and III) healthy adult subjects. Antimicrob Agents Chemother. 2015 Jul;59(7):3956-65. doi: 10.1128/AAC.00498-15. Epub 2015 Apr 20.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2013
• Last Update Submitted That Met QC Criteria: March 12, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Obesity; Ceftaroline; Pharmacokinetics
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Ceftaroline fosamil
• Other Study ID Numbers: TEF-MD-01