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COMPLETEDPhase 1NCT01594255

CAEB071 Thorough QTc Study 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.

Lead sponsor: Novartis Pharmaceuticals•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novartis Pharmaceuticals

Age

18 - 50 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 9, 2012Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment100

Start dateJul 2009

Last updatedMay 9, 2012

Condition

Locations shown

Novartis Investigational Site

Austin, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2012Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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