Clinical trial NCT01648127: Pharmacokinetics of Ceftaroline in Normal and Obese Subjects
Official title: Pharmacokinetics of Ceftaroline in Normal and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety
Keywords: Ceftaroline
Pharmacokinetics
Obesity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2012-07-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects
timeFrame: 12 hours
Secondary outcomes:
measure: To evaluate the safety and tolerability of intravenous ceftaroline
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Keith A Rodvold, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.