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A 2-part Study to Assess Local Tolerability, Safety 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
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.
Show details

- 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.
Show details

- 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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Descriptive Information
Brief Title  ICMJE A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects
Official Title  ICMJE A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects When Ceftaroline Fosamil is Diluted in Various Infusion Volume
Brief SummaryThe purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes.
Detailed DescriptionA Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume
    IV infusion
  • Drug: Placebo in 50 ml infusion volume
    IV infusion
  • Drug: 600 ceftaroline fosamil in 250 ml infusion volume
    IV infusion
  • Drug: Placebo in 250 ml infusion volume
    IV infusion
  • Drug: 600 mg ceftaroline in 100 ml infusion volume
    IV infusion
  • Drug: Placebo in 100 ml infusion volume
    IV infusion
Study Arms  ICMJE
  • Experimental: A
    600 mg ceftaroline fosamil in 50 ml infusion volume
    Intervention: Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume
  • Placebo Comparator: B
    Placebo in 50 ml infusion volume
    Intervention: Drug: Placebo in 50 ml infusion volume
  • Experimental: C
    600 ceftaroline fosamil in 250 ml infusion volume
    Intervention: Drug: 600 ceftaroline fosamil in 250 ml infusion volume
  • Placebo Comparator: D
    Placebo in 250 ml infusion volume
    Intervention: Drug: Placebo in 250 ml infusion volume
  • Experimental: E
    600 mg ceftaroline in 100 ml infusion volume
    Intervention: Drug: 600 mg ceftaroline in 100 ml infusion volume
  • Placebo Comparator: F
    Placebo in 100 ml infusion volume
    Intervention: Drug: Placebo in 100 ml infusion volume
Publications *Edeki T, Kujacic M, Broadhurst H, Li J, Sunzel M. Safety, local tolerability and pharmacokinetics of ceftaroline fosamil administered in a reduced infusion volume. Br J Clin Pharmacol. 2014 Dec;78(6):1291-7. doi: 10.1111/bcp.12465.


*   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: September 13, 2012)
34
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2012)
74
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion DateSeptember 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older 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 CountriesUnited States
 
Administrative Information
NCT Number  ICMJE NCT01577589
Other Study ID Numbers  ICMJE D3720C00015
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 Research Cumberland Avenue London NW10 EW UK
Study Chair:Mirjana Kujacic, MDAstraZeneca Research and DevelopmentSE-431 83 MölndalSweden
PRS AccountPfizer
Verification DateSeptember 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:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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