Ceftaroline China Pharmacokinetics Study

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.

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Detailed Description

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A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ceftaroline q12h

Ceftaroline 600mg q12h

Group Type EXPERIMENTAL

Ceftaroline

Intervention Type DRUG

60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.

Ceftaroline q8h

ceftaroline 600mg q8h

Group Type EXPERIMENTAL

Ceftaroline

Intervention Type DRUG

Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.

Interventions

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Ceftaroline

60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.

Intervention Type DRUG

Ceftaroline

Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures.
* Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
* Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
* Be willing to communicate with the investigator and comply with all study procedures.

Exclusion Criteria

* Creatine clearance \<80 mL/min as calculated by the Cockcroft Gault equation
* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
* Symptoms of any clinically significant illness within 2 weeks of screening.
* Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit 2.
* Blood donation with 3 months of screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes