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Completed

NCT Number: NCT01014247

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

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).

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Key information

Conditions

QTc Evaluation Electrocardiography

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Avelox (Moxifloxacin, BAY12-8039)

Drug

Single dose of 400 mg

Placebo

Drug

Single dose of matching tablet

Primary outcomes

  1. QTc interval at 3 hours

    Time frame: Day 1 of treatment period 1 and 2

Secondary outcomes

  1. Safety variables

    Time frame: Up to last visit of follow up

    Adverse events, clinical laboratory, vital signs, ECG findings

  2. Pharmacokinetic parameters

    Time frame: On different time points

    Cmax, Cmax,norm, tmax

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2009
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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