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

Phase 1

Completed

• Conditions: QTc Evaluation; Electrocardiography
• Interventions: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Placebo

• Registration Number: NCT01014247
• Lead Sponsor: Bayer

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Healthy volunteers
• Age 18-75 years - Normal ECG

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Exclusion Criteria

• Abnormal ECG - Intolerance to fluorochinolones

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Avelox (Moxifloxacin, BAY12-8039)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
QTc interval at 3 hours	Day 1 of treatment period 1 and 2

Secondary Outcome Measures

Name	Time	Method
Safety variables	Up to last visit of follow up	Adverse events, clinical laboratory, vital signs, ECG findings
Pharmacokinetic parameters	On different time points	Cmax, Cmax,norm, tmax