CAEB071 Thorough QTc Study in Healthy Volunteers

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: sotrastaurin; Drug: placebo to sotrastaurin; Drug: Avelox

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594255

CAEB071A2115

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

AEB071 300 mg

Experimental group

Treatment:

Drug: sotrastaurin

Drug: sotrastaurin

AEB071 900 mg

Experimental group

Treatment:

Drug: sotrastaurin

Drug: sotrastaurin

Placebo to AEB071

Placebo Comparator group

Treatment:

Drug: placebo to sotrastaurin

Moxifloxacin

Active Comparator group

Treatment:

Drug: Avelox