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Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation

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ClinicalTrials.gov Identifier: NCT01014247
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : June 3, 2013
Sponsor:
Information provided by:
Bayer

Brief Summary:
The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).

Condition or disease Intervention/treatment Phase
QTc Evaluation Electrocardiography Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Single dose of 400 mg
Placebo Comparator: Arm 2 Drug: Placebo
Single dose of matching tablet



Primary Outcome Measures :
  1. QTc interval at 3 hours [ Time Frame: Day 1 of treatment period 1 and 2 ]

Secondary Outcome Measures :
  1. Safety variables [ Time Frame: Up to last visit of follow up ]
    Adverse events, clinical laboratory, vital signs, ECG findings

  2. Pharmacokinetic parameters [ Time Frame: On different time points ]
    Cmax, Cmax,norm, tmax



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-75 years - Normal ECG Exclusion Criteria:
  • Abnormal ECG - Intolerance to fluorochinolones

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014247


Locations
Australia, Victoria
Melbourne, Victoria, Australia, 3004
Germany
Gießen, Hessen, Germany, 35392
Dresden, Sachsen, Germany, 01307
Singapore
Singapore, Singapore, 119228
Singapore, Singapore, 168752
United Kingdom
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01014247     History of Changes
Other Study ID Numbers: 13796
2009-012363-34 ( EudraCT Number )
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Bayer:
Moxifloxacin

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors