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

Bayer56 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

QTc Evaluation Electrocardiography

Interventions

Avelox (Moxifloxacin, BAY12-8039)DRUG

Single dose of 400 mg

PlaceboDRUG

Single dose of matching tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Melbourne, Victoria, Australia

Unnamed facility

Giessen, Hesse, Germany

Unnamed facility

Dresden, Saxony, Germany

Unnamed facility

Singapore, Singapore

Unnamed facility

Outcomes

Primary Outcomes

QTc interval at 3 hours

Time frame: Day 1 of treatment period 1 and 2

Secondary Outcomes

Safety variables

Adverse events, clinical laboratory, vital signs, ECG findings

Time frame: Up to last visit of follow up

Pharmacokinetic parameters

Cmax, Cmax,norm, tmax

Time frame: On different time points

Data from ClinicalTrials.gov

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