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A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Research Site
Overland Park, Kansas, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Male Volunteers
Sex
Male
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 informed consent prior to any study specific procedures

- Healthy male volunteers aged 18 to 45 years (inclusive) with suitable veins for
cannulation or repeated venepuncture

- Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and
100 kg

- Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine
products) for more than 3 months prior to the start of the study

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

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

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

- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
Systolic blood pressure (SBP) greater than 140 mmHg, Diastolic blood pressure (DBP)
greater than 90 mmHg, Heart rate less than 40 or greater than 85 beats per minute - at
Visit 1

- Prolonged QTcF >450 ms or shortened QTcF

- Any clinically important abnormalities in rhythm, conduction or morphology of resting
ECG that may interfere with the interpretation of QTc interval changes. This includes
volunteers with any of the following: Clinically significant PR (PQ) interval
prolongation, Intermittent second or third degree AV block (Mobitz II type 1,
Wenchebach during sleep is not disqualifying), Incomplete, full or intermittent bundle
branch block (QRS less than 110 ms with normal QRS and T wave morphology is acceptable
if there is no evidence of left ventricular hypertrophy), Abnormal T wave morphology,
particularly in the protocol defined primary lead

NCT01290900
Pfizer
Completed
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

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Descriptive Information
Brief Title  ICMJE A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Official Title  ICMJE A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of a Single Dose of Intravenous Ceftazidime NXL104 (3000/2000 mg) or Ceftaroline Fosamil NXL104 (1500/2000 mg), Compared With Placebo, Using Open-label Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Brief SummaryThis is a single dose study in healthy male volunteers to investigate the effect of high doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Male Volunteers
Intervention  ICMJE
  • Drug: NXL104
    IV Solution
  • Drug: Ceftaroline
    IV Solution
  • Drug: Placebo Infusion
    IV Saline
  • Drug: Ceftazidime
    IV Solution
  • Drug: Moxifloxacin
    Tablet (1)
Study Arms  ICMJE
  • Experimental: CXL104
    2000 mg NXL104 + 1500 mg Ceftaroline (IV)
    Interventions:
    • Drug: NXL104
    • Drug: Ceftaroline
  • Experimental: CAZ104
    Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV)
    Interventions:
    • Drug: NXL104
    • Drug: Placebo Infusion
    • Drug: Ceftazidime
  • Active Comparator: Moxifloxacin
    Moxifloxacin 400mg (1 tablet)
    Intervention: Drug: Moxifloxacin
  • Placebo Comparator: Placebo
    Placebo Infusion (saline)
    Intervention: Drug: Placebo Infusion
Publications *Das S, Armstrong J, Mathews D, Li J, Edeki T. Randomized, placebo-controlled study to assess the impact on QT/QTc interval of supratherapeutic doses of ceftazidime-avibactam or ceftaroline fosamil-avibactam. J Clin Pharmacol. 2014 Mar;54(3):331-40. doi: 10.1002/jcph.199. Epub 2013 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: June 14, 2011)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2011)
45
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed informed consent prior to any study specific procedures
  • Healthy male volunteers aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venepuncture
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for more than 3 months prior to the start of the study

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
  • Any clinically significant abnormalities in physical examination, clinical chemistry, haematology or urinalysis results as judged by the Investigator
  • Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: Systolic blood pressure (SBP) greater than 140 mmHg, Diastolic blood pressure (DBP) greater than 90 mmHg, Heart rate less than 40 or greater than 85 beats per minute - at Visit 1
  • Prolonged QTcF >450 ms or shortened QTcF <340 ms
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes volunteers with any of the following: Clinically significant PR (PQ) interval prolongation, Intermittent second or third degree AV block (Mobitz II type 1, Wenchebach during sleep is not disqualifying), Incomplete, full or intermittent bundle branch block (QRS less than 110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy), Abnormal T wave morphology, particularly in the protocol defined primary lead
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01290900
Other Study ID Numbers  ICMJE D4280C00007
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPaul Newell / Medical Science Director, AstraZeneca
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Paul Newell, MDAstraZeneca
Principal Investigator:David Mathews, MDQuintiles, Inc.
PRS AccountPfizer
Verification DateAugust 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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