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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071

NCT ID: NCT00409929

Last Updated: 2010-10-19

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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This study will evaluate the safety and tolerability of ascending single oral doses greater than 500 mg of AEB071 in healthy subjects

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AEB071

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and/or female subjects from 18-55 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
* Female subjects had to either have been surgically sterilized or be postmenopausal.

Exclusion Criteria

* Smokers
* Use of any prescription drug or over-the-counter medication within 2 weeks prior to dosing, or 2 months for inducers or inhibitors of cytochrome CYP4503A4 (paracetamol acceptable)
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
* History of History of fainting, hypotension when standing up, arrhythmia, acute or chronic bronchospastic disease
* History of clinically significant drug allergy; atopic allergy or a known hypersensitivity to any of the study drugs or drugs similar to the study drugs
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study
* History of immunocompromise (including a positive HIV test result) or drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse or a current positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

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Novartis Investigative Site

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CAEB071A2114

Identifier Type: -

Identifier Source: org_study_id