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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310596

Enrollment

Registered

2006-04-04

Start date

2004-01-31

Completion date

2004-03-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ECG safety

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.

Interventions

DRUGGadopentetate dimeglumine (Magnevist, BAY86-4882)

0,1mmol/kg at 10 mL/15 sec

DRUGMoxifloxacin (BAY12-8039)

400 mg at 0,07 mL/sec over 60 min

DRUGPlacebo

0,9% saline at 0,6mL/kg at bolus rate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse event monitoring, laboratory evaluations	24 hrs postinjection
ECG variables and overall interpretation	24 hrs postinjection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026