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

Last updated on August 9, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects
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
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline
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
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: 600 mg Ceftaroline fosamil
    1 h infusion
  • Drug: Placebo
    1 h infusion
  • Drug: 600 mg Ceftaroline fosamil
    2 h infusion
  • Drug: Placebo
    2 h infusion
  • Experimental: A
    600 mg Ceftaroline fosamil 1 h infusion
    Intervention: Drug: 600 mg Ceftaroline fosamil
  • Experimental: B
    Placebo 1 h infusion
    Intervention: Drug: Placebo
  • Experimental: C
    600 mg Ceftaroline fosamil 2 h infusion
    Intervention: Drug: 600 mg Ceftaroline fosamil
  • Experimental: D
    Placebo 2 h infusion
    Intervention: Drug: Placebo
Yang L, Sunzel M, Xu P, Edeki T, Wilson D, Li J, Li H. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects. Int J Clin Pharmacol Ther. 2015 Aug;53(8):681-91. doi: 10.5414/CP202343.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01612507
D3720C00010
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: David Melnick, MD AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437
Principal Investigator: Elizabeth Tranter, MBCHB MRCP Hammersmith Medicines Cumberland Avenue London NW10 7EW UK
Study Chair: Mirjana Kujacic, MD AstraZeneca Research and DevelopmentSE-431 83 MolndalSweden
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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