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A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Research Site
Stockholm, , Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics, Open Label, CAZ-AVI, CXL, Effect on Intestinal Flora, Safety
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Provision of signed and dated, written informed consent prior to any study specific
procedures

2. Healthy male and female volunteers aged 18 to 45 years (inclusive) with suitable veins
for cannulation or repeated venepuncture.

Females: Female healthy volunteers are authorised to participate in this study if both
of the following criteria are met:

1. A negative serum pregnancy test BOTH at screening AND at admission to the study
centre.

2. Agrees not to attempt pregnancy while receiving investigational product and for a
period of 7 days after last investigational product administration, and agrees to
the use of acceptable methods of contraception (according to instructions) prior
to, during, and for 7 days after the last investigational product administration.

3. Have a body mass index (BMI) between 19 and 30 kg/m2.

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

1. 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.

2. Any clinically significant abnormalities in physical examination, ECG, clinical
chemistry, haematology, coagulation, or urinalysis results, as judged by the
investigator.

3. Pregnant or breastfeeding female healthy volunteers.

4. History of any clinically significant disease or disorder which, in the opinion of the
investigator, may either put the healthy volunteer at risk because of participation in
the study, or influence the results or the healthy volunteer's ability to participate
in the study.

5. Known history of Clostridium difficile infection in last 3 months.

NCT01789528
Pfizer
Completed
A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

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A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers
A Phase 1, Open-label, Multiple-dose, Single Centre Study to Investigate the Effect of Administration of CAZ-AVI and CXL on the Intestinal Flora of Healthy Volunteers.
The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL on the intestinal flora of male and female healthy volunteers after multiple administrations over 7 days. An assessment of the effect on intestinal flora is an important aspect to understand for the safe clinical use of the investigational products and is expected by regulatory agencies.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Pharmacokinetics
  • Open Label
  • CAZ-AVI
  • CXL
  • Effect on Intestinal Flora
  • Safety
  • Drug: CAZ-AVI
    IV infusion
    Other Name: Cohort 1
  • Drug: CXL
    IV infusion
    Other Name: Cohort 2
Experimental: CAZ-AVI or CXL

Cohort 1: CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) by intravenous infusion given over 2 hours, every 8 hours

Cohort 2: CXL (600 mg ceftaroline fosamil and 600 mg avibactam)

Interventions:
  • Drug: CAZ-AVI
  • Drug: CXL
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provision of signed and dated, written informed consent prior to any study specific procedures
  2. Healthy male and female volunteers aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venepuncture.

    Females: Female healthy volunteers are authorised to participate in this study if both of the following criteria are met:

    1. A negative serum pregnancy test BOTH at screening AND at admission to the study centre.
    2. Agrees not to attempt pregnancy while receiving investigational product and for a period of 7 days after last investigational product administration, and agrees to the use of acceptable methods of contraception (according to instructions) prior to, during, and for 7 days after the last investigational product administration.
  3. Have a body mass index (BMI) between 19 and 30 kg/m2.

Exclusion Criteria:

  1. 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.
  2. Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, coagulation, or urinalysis results, as judged by the investigator.
  3. Pregnant or breastfeeding female healthy volunteers.
  4. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study.
  5. Known history of Clostridium difficile infection in last 3 months.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01789528
D4280C00023
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Paul Newell, MD AstraZeneca R&D, Alderly Park, Mereside, SK 104TG, Macclesfield, Cheshire, United Kingdom
Study Chair: Sandhia Ponnarambil, MD AstraZeneca R&D Alderly Park, Parklands, SK 104TF, Macclesfield, Cheshire, United Kingdom
Principal Investigator: Georgios Panagiotidis, MD Clinical Pharmacology Trial Unit, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden
Pfizer
September 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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