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CAEB071 Thorough QTc Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01594255
First received: May 3, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: sotrastaurin
Drug: placebo to sotrastaurin
Drug: Avelox
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Enrollment: 100
Study Start Date: July 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594255

Locations
United States, Texas
Novartis Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01594255     History of Changes
Other Study ID Numbers: CAEB071A2115
Study First Received: May 3, 2012
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Healthy volunteer
QT intervals
ECG
QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs

ClinicalTrials.gov processed this record on May 22, 2013