Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Study Overview
=================
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.

Official Title
-----------------
Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Drug: Ceftaroline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftaroline<br>Ceftaroline intravenous 600 mg single dose | Drug: Ceftaroline<br>* A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ceftaroline, Pharmacokinetics, Obesity