Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Drug Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Ceftaroline

Ceftaroline intravenous 600 mg single dose

Group Type EXPERIMENTAL

Ceftaroline

Intervention Type DRUG

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

Interventions

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Ceftaroline

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

Intervention Type DRUG

Other Intervention Names

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Teflaro

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes