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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: November 12, 2009
Last updated: May 31, 2013
Last verified: May 2013
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
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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

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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-75 years - Normal ECG Exclusion Criteria:
  • Abnormal ECG - Intolerance to fluorochinolones
  Contacts and Locations
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Please refer to this study by its identifier: NCT01014247

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

Additional Information:
Responsible Party: Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc. Identifier: NCT01014247     History of Changes
Other Study ID Numbers: 13796  2009-012363-34 
Study First Received: November 12, 2009
Last Updated: May 31, 2013
Health Authority: Australia: Human Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Food and Drug Administration
Singapore: Health Sciences Authority
United States: Food and Drug Administration

Keywords provided by Bayer:

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