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A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Research Site
Shanghai, , China
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
18-45 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.

- Healthy male and female (of non-child bearing potential) Chinese subjects, with
suitable veins for cannulation or repeated venipuncture

- BMI 19 to 24 kg/m2 inclusive 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

- Any clinical condition requiring the regular use of any medication.

- Consumption of alcohol, drug, tobacco (cigarettes).

- Sensitive to any food, or any serious reaction to carbapenem, cephalosporin, or other
?-lactam antibiotics.

- Severe medical or psychiatric condition or laboratory abnormality.

- Blood donation.

- 12 lead ECG abnormal.

NCT01920399
Pfizer
Completed
A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

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Descriptive Information
Brief Title  ICMJE A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects
Official Title  ICMJE A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Ceftazidime-Avibactam Administered as Single and Repeated Intravenous Doses in Healthy Chinese Subjects
Brief SummaryInvestigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese subjects.This study data will be used to support CAZ-AVI NDA in China.
Detailed DescriptionNot Provided
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: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: CAZ-AVI
    A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9.
  • Drug: 0.9% Normal Saline
    A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    IV infusions of 0.9% normal saline
    Intervention: Drug: 0.9% Normal Saline
  • Experimental: CAZ-AVI
    IV infusion of AVI 500 mg + CAZ 2000 mg.
    Intervention: Drug: CAZ-AVI
Publications *Li J, Learoyd M, Qiu F, Zhu L, Edeki T. A Randomized, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Ceftazidime-Avibactam in Healthy Chinese Subjects. Clin Drug Investig. 2016 Feb;36(2):119-26. doi: 10.1007/s40261-015-0347-x.


*   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: July 3, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2013)
16
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion DateNovember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study-specific procedures.
  • Healthy male and female (of non-child bearing potential) Chinese subjects, with suitable veins for cannulation or repeated venipuncture
  • BMI 19 to 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Key Exclusion Criteria:

  • Any clinical condition requiring the regular use of any medication.
  • Consumption of alcohol, drug, tobacco (cigarettes).
  • Sensitive to any food, or any serious reaction to carbapenem, cephalosporin, or other ?-lactam antibiotics.
  • Severe medical or psychiatric condition or laboratory abnormality.
  • Blood donation.
  • 12 lead ECG abnormal.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920399
Other Study ID Numbers  ICMJE D4280C00020
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Furong QiuShuguang Hospital affiliated with Shanghai University of TCM
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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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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