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

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ClinicalTrials.gov Identifier: NCT01920399
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Investigate 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CAZ-AVI Drug: 0.9% Normal Saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: 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
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ceftazidime

Arm Intervention/treatment
Placebo Comparator: Placebo
IV infusions of 0.9% normal saline
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.

Experimental: CAZ-AVI
IV infusion of AVI 500 mg + CAZ 2000 mg.
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.




Primary Outcome Measures :
  1. Safety and Tolerability:Adverse events, vital signs, ECGs, clinical laboratory measurements, physical examinations, oral body temperature [ Time Frame: Routine safety assessments, throughout the period that subjects receive CAZ-AVI/PLACEBO up to 5 days following discontinuation of study treatment ]
    AE: The onset of an AE relative to treatment will be calculated as the time difference between the onset (date and time) of the AE and the start time of the last dose (date and time) prior to the AE; the duration of a resolved AE will be calculated as the difference between the resolution (date and time) of the AE and the onset (date and time) of the AE. Vital signs and oral temperature:Change in BP, pulse rate and oral temperature at each post treatment time point will be calculated as the post treatment measurement value minus the baseline value observed on Day -1. Physical examination: complete physical examination and brief physical examination. ECG: heart rate, RR, PR, QRS, and QT intervals from the 12-lead ECG and the derived variable QTcF. Safety laboratory (hematology, chemistry and urinalysis): Change in laboratory test value at each post treatment time point will be calculated as the post treatment value minus the baseline value observed on Day -1 .


Secondary Outcome Measures :
  1. Plasma PK parameters for CAZ and AVI of single dose: Cmax, tmax, Clast, tlast, AUC(0-t), AUC, AUC(0-8), λz, t1/2, Vss, Vz, CL, MRT, etc. [ Time Frame: single IV infusion on Day 1 ]
  2. Plasma PK parameters for CAZ and AVI of multi dose: the trough concentration Cmin [ Time Frame: Days 6, 7, 8 ]
  3. Plasma PK parameters for CAZ and AVI of repeated infusion: Cmax, tmax, Clast, tlast, AUC(0-t), AUC, AUC(0-8), λz, t1/2, Vss, Vz, CL, MRT, etc. [ Time Frame: After repeated infusion On Day 9 ]
  4. Urine PK parameters for CAZ and AVI of single and repeated infusion: Cumulated urinary excretion (amount), percentage of cumulated urinary recovery (% dose) and renal clearance (CLr) [ Time Frame: Day 1 and Day 9 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 β-lactam antibiotics.
  • Severe medical or psychiatric condition or laboratory abnormality.
  • Blood donation.
  • 12 lead ECG abnormal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920399


Locations
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China
Research Site
Shanghai, China
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Furong Qiu Shuguang Hospital affiliated with Shanghai University of TCM

Additional Information:
Publications:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01920399     History of Changes
Other Study ID Numbers: D4280C00020
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
CAZ-AVI China phase I PK study

Additional relevant MeSH terms:
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Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action