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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01594255

Enrollment

100

Registered

2012-05-09

Start date

2009-07-31

Completion date

Unknown

Last updated

2012-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteer, QT intervals, ECG, QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs

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.

Interventions

DRUGsotrastaurin

DRUGplacebo to sotrastaurin

DRUGAvelox

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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/

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026