Drug Safety
Conditions
Keywords
Ceftaroline, Pharmacokinetics, Obesity
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.
Interventions
DRUGCeftaroline
A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion
Sponsors
Forest Laboratories
Keith A. Rodvold
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects | 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of intravenous ceftaroline | 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 |
Countries
United States
Outcome results
None listed