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

Last updated on March 14, 2019

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Study Location
Research Site
London, , United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT01664065
Pfizer
Completed
A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects

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[email protected]

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