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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CXL104

2000 mg NXL104 + 1500 mg Ceftaroline (IV)

Group Type EXPERIMENTAL

NXL104

Intervention Type DRUG

IV Solution

Ceftaroline

Intervention Type DRUG

IV Solution

CAZ104

Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV)

Group Type EXPERIMENTAL

NXL104

Intervention Type DRUG

IV Solution

Placebo Infusion

Intervention Type DRUG

IV Saline

Ceftazidime

Intervention Type DRUG

IV Solution

Moxifloxacin

Moxifloxacin 400mg (1 tablet)

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Tablet (1)

Placebo

Placebo Infusion (saline)

Group Type PLACEBO_COMPARATOR

Placebo Infusion

Intervention Type DRUG

IV Saline

Interventions

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NXL104

IV Solution

Intervention Type DRUG

Ceftaroline

IV Solution

Intervention Type DRUG

Placebo Infusion

IV Saline

Intervention Type DRUG

Ceftazidime

IV Solution

Intervention Type DRUG

Moxifloxacin

Tablet (1)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes