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Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

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ClinicalTrials.gov Identifier: NCT01648127
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : March 14, 2013
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Keith A. Rodvold, University of Illinois

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.

Condition or disease Intervention/treatment Phase
Drug Safety Drug: Ceftaroline Phase 1

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  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacokinetics of Ceftaroline in Normal and Obese Subjects
Study Start Date : July 2012
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Teflaro



Primary Outcome Measures :
  1. Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects [ Time Frame: 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 :
  1. To evaluate the safety and tolerability of intravenous ceftaroline [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648127


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Keith A. Rodvold
Forest Laboratories
Investigators
Principal Investigator: Keith A Rodvold, Pharm.D. University of Illinois at Chicago

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keith A. Rodvold, Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT01648127     History of Changes
Other Study ID Numbers: TEF-MD-01
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by Keith A. Rodvold, University of Illinois:
Ceftaroline
Pharmacokinetics
Obesity

Additional relevant MeSH terms:
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents