CAEB071 Thorough QTc Study in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AEB071 300 mg

Group Type EXPERIMENTAL

sotrastaurin

Intervention Type DRUG

AEB071 900 mg

Group Type EXPERIMENTAL

sotrastaurin

Intervention Type DRUG

Placebo to AEB071

Group Type PLACEBO_COMPARATOR

placebo to sotrastaurin

Intervention Type DRUG

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Avelox

Intervention Type DRUG

Interventions

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sotrastaurin

Intervention Type DRUG

sotrastaurin

Intervention Type DRUG

placebo to sotrastaurin

Intervention Type DRUG

Avelox

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes