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A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in 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.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT01612507
Pfizer
Completed
A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects

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[email protected]

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