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Completed

NCT Number: NCT01594255

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigational Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sotrastaurin

Drug

placebo to sotrastaurin

Drug

Avelox

Drug

Primary outcomes

  1. Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
May 9, 2012
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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