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

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Time Lagged, Parallel Group, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AEB071 Doses Greater Than 500 mg in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409929
• Other study ID #: CAEB071A2114
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2006
• Last updated: October 18, 2010
• Start date: June 2006

Study information

• Verified date: October 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AEB071

Locations

Country	Name	City	State
Switzerland	Novartis Investigative Site	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects.
Primary	Maximum Tolerated Dose
Secondary	Assess the pharmacokinetics of single oral doses of AEB071 at the end of study
Secondary	Measure inhibition of lymphocytes activation following rising oral doses of AEB071 in healthy subjects after each single dose
Secondary	Measure the pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AEB071 in healthy subjects after each single dose
Secondary	Conduct exploratory genomic studies to identify gene expression patterns of blood cells at the end of study