Trial Condition(s):
QTc evaluation, Electrocardiography
Influence of moxifloxacin on QTc interval in healthy subjects for positive control validation
Bayer Identifier:
13796
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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).
Inclusion Criteria
- Healthy volunteers - Age 18-75 years - Normal ECG
Exclusion Criteria
- Abnormal ECG - Intolerance to fluorochinolones
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Giessen und Marburg Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nucleus Network Ltd Melbourne, Australia, 3004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Hospital Singapore , Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Heart Centre Singapore, Singapore, 168752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hammersmith Hospital London, United Kingdom, W12 0HS | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- QTc interval at 3 hoursTimeframe: Day 1 of treatment period 1 and 2
Secondary Outcome
- Safety variablesAdverse events, clinical laboratory, vital signs, ECG findingsTimeframe: Up to last visit of follow up
- Pharmacokinetic parametersCmax, Cmax,norm, tmaxTimeframe: On different time points
Additional Information
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