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: March 21, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2009

Last Updated Date

March 21, 2013

Start Date ^ICMJE

November 2009

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

QTc interval at 3 hours [ Time Frame: Day 1 of treatment period 1 and 2 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01014247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

QTc Evaluation
Electrocardiography

Intervention ^ICMJE

Drug: Avelox (Moxifloxacin, BAY12-8039)
Single dose of 400 mg
Drug: Placebo
Single dose of matching tablet

Study Arm (s)

Active Comparator: Arm 1
Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
Placebo Comparator: Arm 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteers
Age 18-75 years - Normal ECG Exclusion Criteria:
Abnormal ECG - Intolerance to fluorochinolones

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Germany, Singapore, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01014247

Other Study ID Numbers ^ICMJE

13796, 2009-012363-34

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

March 2013

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

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