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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 February 23, 2019

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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.
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- 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.
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- 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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[email protected]

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