CAEB071 Thorough QTc Study in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: sotrastaurin; Drug: placebo to sotrastaurin; Drug: Avelox

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Novartis Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Moxifloxacin	Drug: Avelox
Experimental: AEB071 300 mg	Drug: sotrastaurin
Experimental: AEB071 900 mg	Drug: sotrastaurin
Placebo Comparator: Placebo to AEB071	Drug: placebo to sotrastaurin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals	24 hours
Tolerability of 300 and 900 mg of AEB071.	72 hours

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: ECG; Healthy volunteer; QT intervals; QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: CAEB071A2115