QTc Evaluation, Electrocardiography
Conditions
Keywords
Moxifloxacin
Brief 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).
Interventions
Single dose of 400 mg
DRUGPlacebo
Single dose of matching tablet
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Age 18-75 years - Normal ECG
Exclusion criteria
* Abnormal ECG - Intolerance to fluorochinolones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QTc interval at 3 hours | Day 1 of treatment period 1 and 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety variables | Up to last visit of follow up | Adverse events, clinical laboratory, vital signs, ECG findings |
| Pharmacokinetic parameters | On different time points | Cmax, Cmax,norm, tmax |
Countries
Australia, Germany, Singapore, United Kingdom
Outcome results
None listed