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CAEB071 Thorough QTc Study in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594255
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : May 9, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: sotrastaurin Drug: placebo to sotrastaurin Drug: Avelox Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : July 2009
Actual Primary Completion Date : September 2009

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

Primary Outcome Measures :
  1. Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals [ Time Frame: 24 hours ]
  2. Tolerability of 300 and 900 mg of AEB071. [ Time Frame: 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01594255

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United States, Texas
Novartis Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01594255    
Other Study ID Numbers: CAEB071A2115
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Healthy volunteer
QT intervals
QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents