Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).

Detailed Description
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This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Official Title
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Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
* Drug: Moxifloxacin (BAY12-8039)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities Non-smoker Exclusion Criteria: History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* 0,1mmol/kg at 10 mL/15 sec<br>|
| Experimental: Arm 2<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* same dose as arm 1 at bolus rate (2mL/sec)<br>|
| Experimental: Arm 3<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* 0,3mmol/kg at 10 mL/15 sec<br>|
| Experimental: Arm 4<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* same dose as arm 3 at bolus rate (2mL/sec)<br>|
| Active Comparator: Arm 5<br> | Drug: Moxifloxacin (BAY12-8039)<br>* 400 mg at 0,07 mL/sec over 60 min<br>|
| Placebo Comparator: Arm 6<br> | Drug: Placebo<br>* 0,9% saline at 0,6mL/kg at bolus rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary study variable was heart-rate corrected QT (QTc) interval |  | Within 15 min postinjection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event monitoring, laboratory evaluations |  | 24 hrs postinjection | 
| ECG variables and overall interpretation |  | 24 hrs postinjection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG safety