CAEB071 Thorough QTc Study in Healthy Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Moxifloxacin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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