This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the
QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
Drug: placebo to sotrastaurin
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Locations near you
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Full eligibility criteria for NCT01594255
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Smokers and tobacco product users (in the previous 3 months).
Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements
(vitamins included) within two (2) weeks prior to initial dosing.
A marked baseline prolongation of QT/QTcF interval
Presence of clinically significant illness
Other protocol-defined inclusion/exclusion criteria may apply
All locations for NCT01594255
United States (1)
Novartis Investigational Site
Austin, Texas, United States, 78744
View full eligibility
Tris trial is registered with FDA with number: NCT01594255. The sponsor of the trial is Novartis Pharmaceuticals and it is looking for 100 volunteers for the current phase.
Official trial title: A Randomized, Partially Blinded, 4-period, Crossover Study to Assess the Effects of Single-dose AEB071 Administration (300 and 900 mg) on Electrocardiographic QT Intervals Compared to Placebo in Healthy Volunteers
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