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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01014247
First received: November 12, 2009
Last updated: May 31, 2013
Last verified: May 2013

November 12, 2009
May 31, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014247 on ClinicalTrials.gov Archive Site
  • Safety variables [ Time Frame: Up to last visit of follow up ] [ Designated as safety issue: Yes ]
    Adverse events, clinical laboratory, vital signs, ECG findings
  • Pharmacokinetic parameters [ Time Frame: On different time points ] [ Designated as safety issue: No ]
    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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Singapore,   United Kingdom
 
NCT01014247
13796, 2009-012363-34
No
Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

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