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

Last updated on November 14, 2019

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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Descriptive Information
Brief Title  ICMJE A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects
Official Title  ICMJE 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
Brief SummaryThe purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose regimens of Ceftaroline
Detailed DescriptionA 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2012)
41
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2012)
40
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion DateNovember 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01612507
Other Study ID Numbers  ICMJE D3720C00010
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:David Melnick, MDAstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437
Principal Investigator:Elizabeth Tranter, MBCHB MRCPHammersmith Medicines Cumberland Avenue London NW10 7EW UK
Study Chair:Mirjana Kujacic, MDAstraZeneca Research and DevelopmentSE-431 83 MolndalSweden
PRS AccountPfizer
Verification DateAugust 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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