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
NCT01290900
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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
- 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
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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 Summary | This 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 Description | Not 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 |
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| Study Arms ICMJE |
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| 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 | 54 | ||||||
| Original Estimated Enrollment ICMJE | 45 | ||||||
| Actual Study Completion Date ICMJE | May 2011 | ||||||
| Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Paul Newell / Medical Science Director, AstraZeneca | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | August 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||