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

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: AEB071

Study type

Interventional

Funder types

Industry

Identifiers

CAEB071A2114

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Additional protocol-defined inclusion/exclusion criteria may apply