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A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects

Last updated on November 7, 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.
Renal Disease
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 signed and dated, written informed consent prior to any study specific
procedures

- Male and female subjects aged 18 to 75 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 3 months 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 35 kg/m2 and weigh at between 50 and 110
kg

- Haematocrit level higher than 30% at screening and baseline for each treatment period

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- Any clinically significant abnormalities in clinical chemistry, haematology, or
urinalysis results, as judged by the investigator

- Any clinically important abnormalities in rhythm, conduction, or morphology of resting
ECG that may interfere with the interpretation of QTc interval changes

- 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

- Receiving any dialysis treatment other than intermittent haemodialysis

NCT01664065
Pfizer
Completed
A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects

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Descriptive Information
Brief Title  ICMJE A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects
Official Title  ICMJE An Open-label, Nonrandomised, Phase I Study to Assess the Pharmacokinetics of Ceftaroline After Intravenous Administration of aSingle Dose of Ceftaroline Fosamil (200 mg) to Patients With End-stage Renal Disease Undergoing Haemodialysis When Compared to a Single Dose of Ceftaroline Fosamil (600 mg)
Brief SummaryThe purpose of this study is to assess the safety, tolerability and pharmacokinetics of Ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function
Detailed DescriptionAn Open-label, Nonrandomised, Phase I Study to Assess the Pharmacokinetics of Ceftaroline After Intravenous Administration of aSingle Dose of Ceftaroline Fosamil (200 mg) to Patients with End-stage Renal Disease Undergoing Haemodialysis when Compared to a Single Dose of Ceftaroline Fosamil (600 mg)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Disease
Intervention  ICMJE
  • Drug: 200 mg Ceftaroline fosamil
    1 h infusion
  • Drug: 600 mg Ceftaroline fosamil
    1 h infusion
Study Arms  ICMJE
  • Experimental: AZ drug: A
    200 mg Ceftaroline fosamil 1h infusion
    Intervention: Drug: 200 mg Ceftaroline fosamil
  • Experimental: AZ drug: B
    600 mg Ceftaroline fosamil 1h infusion
    Intervention: Drug: 600 mg Ceftaroline fosamil
Publications *Sunzel M, Learoyd M, Li J, Li Y, Ngo N, Edeki T. An open-label, non-randomised, phase 1, single-dose study to assess the pharmacokinetics of ceftaroline in patients with end-stage renal disease requiring intermittent haemodialysis. Int J Antimicrob Agents. 2015 Dec;46(6):682-8. doi: 10.1016/j.ijantimicag.2015.09.009. Epub 2015 Oct 22.


*   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: January 15, 2014)
15
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2012)
16
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion DateNovember 2013   (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
  • Male and female subjects aged 18 to 75 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 3 months 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 35 kg/m2 and weigh at between 50 and 110 kg
  • Haematocrit level higher than 30% at screening and baseline for each treatment period

Exclusion criteria:

  • History or presence of gastrointestinal, hepatic, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
  • 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
  • Receiving any dialysis treatment other than intermittent haemodialysis
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 Countries  
 
Administrative Information
NCT Number  ICMJE NCT01664065
Other Study ID Numbers  ICMJE D3720C00012
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 Pharmaceuticals;C2C-716 1800 Concord PikePO. Box 15437Wilmington De 19850-5437
Principal Investigator:Arpeat Kaviya, MBChB, MRCPQuintiles Drug Research Unit at Guy's Hospital 6 Newcomen St
Study Chair:Mirjana Kujacic, MDAstraZeneca Research and Development SE-431 83 Mölndal
PRS AccountPfizer
Verification DateSeptember 2017

ICMJE     Data element required by the

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

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