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
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov 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:
Moxifloxacin

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014