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
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 9/2/2017 |
Start Date: | February 2011 |
End Date: | May 2011 |
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
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
doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT
interval
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
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