CAEB071 Thorough QTc Study in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01594255

Run by

Novartis Pharmaceuticals

People needed

100

Starts

2009-07-01

Last updated by the study team

2012-05-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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