Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Keith A. Rodvold

Status and phase: Completed; Phase 1

Conditions: Drug Safety

Treatments: Drug: Ceftaroline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01648127

TEF-MD-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Ceftaroline

Experimental group

Description:

Ceftaroline intravenous 600 mg single dose

Treatment:

Drug: Ceftaroline