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

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

November 12, 2009
November 16, 2009
June 3, 2013
November 2009
June 2010   (Final data collection date for primary outcome measure)
QTc interval at 3 hours [ Time Frame: Day 1 of treatment period 1 and 2 ]
Same as current
Complete list of historical versions of study NCT01014247 on Archive Site
  • 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
Not Provided
Not Provided
Not Provided
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
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
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).
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • QTc Evaluation
  • Electrocardiography
  • Drug: Avelox (Moxifloxacin, BAY12-8039)
    Single dose of 400 mg
  • Drug: Placebo
    Single dose of matching tablet
  • Active Comparator: Arm 1
    Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-75 years - Normal ECG Exclusion Criteria:
  • Abnormal ECG - Intolerance to fluorochinolones
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Singapore,   United Kingdom
2009-012363-34 ( EudraCT Number )
Not Provided
Not Provided
Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
Not Provided
Study Director: Bayer Study Director Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP