Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00310596
- Lead Sponsor
- Bayer
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 3 Gadopentetate dimeglumine (Magnevist, BAY86-4882) - Arm 2 Gadopentetate dimeglumine (Magnevist, BAY86-4882) - Arm 1 Gadopentetate dimeglumine (Magnevist, BAY86-4882) - Arm 6 Placebo - Arm 4 Gadopentetate dimeglumine (Magnevist, BAY86-4882) - Arm 5 Moxifloxacin (BAY12-8039) -
- Primary Outcome Measures
Name Time Method The primary study variable was heart-rate corrected QT (QTc) interval Within 15 min postinjection
- Secondary Outcome Measures
Name Time Method Adverse event monitoring, laboratory evaluations 24 hrs postinjection ECG variables and overall interpretation 24 hrs postinjection