Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071
Lead Sponsor:
Novartis
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and tolerability of ascending single oral doses greater than 500 mg of AEB071 in healthy subjects
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00409929
Start Date
June 1 2006
Last Update
October 19 2010
Active Locations (1)
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1
Novartis Investigative Site
Bern, Switzerland