A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched 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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function

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Detailed Description

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An Open-label, Nonrandomised, Phase I Study to Assess the Pharmacokinetics of Ceftaroline After Intravenous Administration of aSingle Dose of Ceftaroline Fosamil (200 mg) to Patients with End-stage Renal Disease Undergoing Haemodialysis when Compared to a Single Dose of Ceftaroline Fosamil (600 mg)

Conditions

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Renal Disease

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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AZ drug: A

200 mg Ceftaroline fosamil 1h infusion

Group Type EXPERIMENTAL

200 mg Ceftaroline fosamil

Intervention Type DRUG

1 h infusion

AZ drug: B

600 mg Ceftaroline fosamil 1h infusion

Group Type EXPERIMENTAL

600 mg Ceftaroline fosamil

Intervention Type DRUG

1 h infusion

Interventions

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200 mg Ceftaroline fosamil

1 h infusion

Intervention Type DRUG

600 mg Ceftaroline fosamil

1 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
* Male and female subjects aged 18 to 75 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 3 months 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 35 kg/m2 and weigh at between 50 and 110 kg
* Haematocrit level higher than 30% at screening and baseline for each treatment period

Exclusion Criteria

* History or presence of gastrointestinal, hepatic, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
* 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
* Receiving any dialysis treatment other than intermittent haemodialysis

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes