check_circleStudy Completed

QTc evaluation, Electrocardiography

Bayer Identifier:

13796

ClinicalTrials.gov Identifier:

NCT01014247

EudraCT Number:

2009-012363-34

EU CT Number:

Not Available
Influence of moxifloxacin on QTc interval in healthy subjects for positive control validation

Trial 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).

Key Participants Requirements

Sex

Both

Age

18 - 75 Years

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

  • - Abnormal ECG - Intolerance to fluorochinolones

Trial summary

Enrollment Goal
56
Trial Dates
November 2009 - June 2010
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Universitätsklinikum Giessen und MarburgGießen, 35392, Germany
Completed
Nucleus Network LtdMelbourne, 3004, Australia
Completed
National University HospitalSingapore, 119228, Singapore
Completed
National Heart CentreSingapore, 168752, Singapore
Terminated
Hammersmith HospitalLondon, W12 0HS, United Kingdom

Primary Outcome

  • QTc interval at 3 hours
    date_rangeTime Frame:
    Day 1 of treatment period 1 and 2
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Safety variables
    Adverse events, clinical laboratory, vital signs, ECG findings
    date_rangeTime Frame:
    Up to last visit of follow up
    enhanced_encryption
    Safety Issue:
    Yes
  • Pharmacokinetic parameters
    Cmax, Cmax,norm, tmax
    date_rangeTime Frame:
    On different time points
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.