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A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects

Last updated on February 21, 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.
Healthy
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 informed consent prior to any study specific requirements

- 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

- Male volunteers must be willing to use barrier contraception from the first day of
dosing until 3 months after the last dose of IP.

- Have a body mass index (BMI) between 18 and 30 kg/m2, and weigh at least 50 kg

- Healthy male and/or female volunteers between the ages of 18 to 75 years inclusive,
with veins on the back of both hands and both forearms suitable for cannulation or
repeated venipuncture.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Use of any other investigational compound or participation in another clinical trial
within 1 month prior to first administration of IP in this study

- History of any clinically significant disease or disorder (e.g., neurological,
haematological, psychiatric, gastrointestinal, hepatic, renal disease)

- Positive serology result on screening for serum hepatitis B surface antigen, hepatitis
C antibody (HCV), or human immunodeficiency virus (HIV)

- History or presence of gastrointestinal, hepatic, or renal disease or any other
condition known to interfere with the absorption, distribution, metabolism or
excretion of drugs

- Any clinically significant abnormalities in the physical examination, lab, 12-lead ECG
or vital signs as judged by the investigator

NCT01577589
Pfizer
Completed
A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects

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[email protected]

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