NCT01594255

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

May 3, 2012

Last Update Submit

May 7, 2012

Conditions

Healthy

Keywords

Healthy volunteerQT intervalsECGQT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (2)

  • 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

Study Arms (4)

AEB071 300 mg

EXPERIMENTAL
Drug: sotrastaurin

AEB071 900 mg

EXPERIMENTAL
Drug: sotrastaurin

Placebo to AEB071

PLACEBO COMPARATOR
Drug: placebo to sotrastaurin

Moxifloxacin

ACTIVE COMPARATOR
Drug: Avelox

Interventions

sotrastaurinDRUG
AEB071 300 mg
placebo to sotrastaurinDRUG
Placebo to AEB071
AveloxDRUG
Moxifloxacin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

sotrastaurinMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 9, 2012

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(1)