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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33181-3405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Study Completion (ACTUAL): March 1, 2004

Study Registration Dates

• First Submitted: March 31, 2006
• First Submitted That Met QC Criteria: April 3, 2006
• First Posted (ESTIMATE): April 4, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: ECG safety
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 91024; 305340