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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014247
First Posted: November 16, 2009
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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 Intervention Phase
QTc Evaluation Electrocardiography Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

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


Enrollment: 56
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: November 12, 2009
First Posted: November 16, 2009
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