Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Drug Safety Clinical Trial

Official title:

Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648127
• Other study ID #: TEF-MD-01
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2012
• Last updated: March 12, 2013
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Drug Safety

Intervention

Drug:
• Ceftaroline
A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Keith A. Rodvold	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes