A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy 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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline

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Detailed Description

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A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

600 mg Ceftaroline fosamil 1 h infusion

Group Type EXPERIMENTAL

600 mg Ceftaroline fosamil

Intervention Type DRUG

1 h infusion

B

Placebo 1 h infusion

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

1 h infusion

C

600 mg Ceftaroline fosamil 2 h infusion

Group Type EXPERIMENTAL

600 mg Ceftaroline fosamil

Intervention Type DRUG

2 h infusion

D

Placebo 2 h infusion

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

2 h infusion

Interventions

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600 mg Ceftaroline fosamil

1 h infusion

Intervention Type DRUG

Placebo

1 h infusion

Intervention Type DRUG

600 mg Ceftaroline fosamil

2 h infusion

Intervention Type DRUG

Placebo

2 h infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures including the optional safety biomarker analysis
* Healthy male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
* Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 1 month prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational drug
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant abnormalities in the physical examination, 12-lead ECG, or vital signs, as judged by the Investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes