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NCT01014247 Clinical Trial

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

Electrocardiography Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01014247
Other study ID # 13796
Secondary ID 2009-012363-34
Status Completed
Phase Phase 1
First received November 12, 2009
Last updated May 31, 2013
Start date November 2009
Est. completion date June 2010

Study information
Verified date May 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Food and Drug AdministrationSingapore: Health Sciences AuthorityUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

- Age 18-75 years - Normal ECG Exclusion Criteria:

- Abnormal ECG - Intolerance to fluorochinolones

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Germany,  Singapore,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary QTc interval at 3 hours Day 1 of treatment period 1 and 2 Yes
Secondary Safety variables Adverse events, clinical laboratory, vital signs, ECG findings Up to last visit of follow up Yes
Secondary Pharmacokinetic parameters Cmax, Cmax,norm, tmax On different time points No
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