Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Keith A. Rodvold, University of Illinois
ClinicalTrials.gov Identifier:
NCT01648127
First received: July 16, 2012
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Drug Safety
Drug: Ceftaroline
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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:
  • To evaluate the safety and tolerability of intravenous ceftaroline [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events Number of participants with changes in clinical laboratories Number of participants with changes in vital sign assessments


Enrollment: 32
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Keith A. Rodvold, Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT01648127     History of Changes
Other Study ID Numbers: TEF-MD-01
Study First Received: July 16, 2012
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Ceftaroline
Pharmacokinetics
Obesity

ClinicalTrials.gov processed this record on August 19, 2014